FDA Registration
Active
🇺🇸 United States
HR PHARMACEUTICALS, INC d/b/a HR HealthCare
Reg #: 3008502431
·
FEI: 3008502431
·
Expires 2026
Products
21
Proprietary Names
1
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- HR PHARMACEUTICALS, INC d/b/a HR HealthCare
- Registration Number
- 3008502431
- FEI Number
- 3008502431
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3630 Concord Rd
- City
- York
- State
- PA
- ZIP
- 17402
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030293
Owner / Operator
- Firm Name
- HR Pharmaceuticals, Inc d/b/a HR HealthCare
- Operator Number
- 10032609
- Address
- 2600 Eastern Boulevard, Suite 201
- City
- York
- State
- PA
- Postal Code
- 17402
- Country
- US
- Correspondent
- Colby Wiesman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2025-01-03 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2023-01-31 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-01-24 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2024-01-23 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2026-02-02 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2018-07-10 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-01-23 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2022-07-26 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2010-05-28 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2024-03-20 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-09-11 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-01-23 |
| Lubricant, Vaginal, Patient | MMS | Class 1 | General Hospital | No | 2010-05-28 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2022-12-07 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2023-08-18 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 2023-08-18 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2024-01-23 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2024-01-23 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2024-01-23 |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | Class 1 | Gastroenterology, Urology | No | 2023-11-29 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2025-01-03 |
Proprietary Names
HR Lubricating Jelly
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device