Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, closed-ended FDA UDI
- Device Name
- RUSCH CARE Premium Drain Bag FDA UDI
- Model / Reference
- IPN029795 FDA UDI
- Description
- RUSCH CARE Premium Drain Bag FDA UDI
Identifiers
- Catalog Number
- 390000 FDA UDI
- Primary DI / UDI-DI
- 14026704666109 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, closed-ended FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-wearable adult urine collection bag, closed-ended
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-wearable adult urine collection bag, closed-ended.
- Disposable Urinary Leg Bag — GCMEDICA ENTERPRISE LTD.(WUXI) · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Disposable Urinary Leg Bag — GCMEDICA ENTERPRISE LTD.(WUXI) · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Disposable Urinary Drainage Bag — GCMEDICA ENTERPRISE LTD.(WUXI) · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI fb774c0f-8ed1-4d4a-a1d2-2e3f51ca9b9a 35 fields · synced May 31, 2026