Regulations research / FDA data / Establishments and listings / Catheter, Retention Type, Balloon Establishments and listings Catheter, Retention Type, Balloon HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Manufacture Medical Device Reg. 3008502431 EZL
K number K200556
Establishment type Manufacture Medical Device Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EZL
Created date 2020-04-29
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Catheter, Retention Type, Balloon
Medical specialty description Gastroenterology, Urology
Regulation number 876.5130
Device class 2 Establishments and listings Catheter, Straight HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 3008502431 EZD
K number K260502
Establishment type Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EZD
Created date 2026-03-17
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Catheter, Straight
Medical specialty description Gastroenterology, Urology
Regulation number 876.5130
Device class 2 Establishments and listings Dressing, Wound, Occlusive HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 Reg. 3008502431 NAD
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code NAD
Created date 2024-01-23
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Dressing, Wound, Occlusive
Medical specialty description General, Plastic Surgery
Regulation number 878.4020
Device class 1 Establishments and listings HR Lubricating Jelly HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Manufacture Medical Device Reg. 3008502431 MMS
Proprietary name HR Lubricating Jelly
Establishment type Manufacture Medical Device Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code MMS
Created date 2010-05-28
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Lubricant, Vaginal, Patient
Medical specialty description General Hospital
Regulation number 880.6375
Device class 1 Establishments and listings Holder, Ureteral Catheter HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 3008502431 EYJ
Establishment type Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EYJ
Created date 2022-12-07
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Holder, Ureteral Catheter
Medical specialty description Gastroenterology, Urology
Regulation number 876.5130
Device class 1 Establishments and listings Catheter, Straight HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 3008502431 EZD
K number K251274
Establishment type Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EZD
Created date 2026-02-02
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Catheter, Straight
Medical specialty description Gastroenterology, Urology
Regulation number 876.5130
Device class 2 Establishments and listings Catheter, Straight HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 Reg. 3008502431 EZD
K number K222677
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EZD
Created date 2024-01-24
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Catheter, Straight
Medical specialty description Gastroenterology, Urology
Regulation number 876.5130
Device class 2 Establishments and listings HR Lubricating Jelly HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Manufacture Medical Device Reg. 3008502431 MUI
Proprietary name HR Lubricating Jelly
Establishment type Manufacture Medical Device Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code MUI
Created date 2010-05-28
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Media, Coupling, Ultrasound
Medical specialty description Radiology
Regulation number 892.1570
Device class 2 Establishments and listings Irrigator, Ostomy HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 Reg. 3008502431 EXD
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EXD
Created date 2023-08-18
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Irrigator, Ostomy
Medical specialty description Gastroenterology, Urology
Regulation number 876.5895
Device class 2 Establishments and listings Catheter, Retention Type, Balloon HR PHARMACEUTICALS, INC d/b/a HR HealthCare · York, US
Complaint File Establishment per 21 CFR 820.198 Reg. 3008502431 EZL
K number K173340
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 3008502431
FEI number 3008502431
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Address line 1 3630 Concord Rd
City York
State code PA
Iso country code US
Zip code 17402 Owner operator
Firm name HR Pharmaceuticals, Inc d/b/a HR HealthCare
Owner operator number 10032609 Official correspondent
First name Colby
Last name Wiesman
Phone number x-717-2521110-x Contact address
Address 1 2600 Eastern Boulevard
Address 2 Suite 201
City York
State code PA
Iso country code US
Postal code 17402 Products
Product code EZL
Created date 2024-01-23
Owner operator number 10032609 Harmonized identifiers (openFDA)
Device name Catheter, Retention Type, Balloon
Medical specialty description Gastroenterology, Urology
Regulation number 876.5130
Device class 2 31 records share this identifier (an establishment lists each device separately); the first 10 are shown.
Wholesale access for licensed clinicians. Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.
Data from openFDA , FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.
