Identity
- Trade Name
- Vive FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, closed-ended FDA UDI
- Device Name
- Urinary Drainage Bag (Leg) 3PK FDA UDI
- Model / Reference
- LVA3080PAK3 FDA UDI
- Description
- Urinary Drainage Bag (Leg) 3PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113579986 FDA UDI
- FDA Product Code
- FAQ FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, closed-ended FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Non-wearable adult urine collection bag, closed-ended
Vive by Vive Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Vive Health Llc
Sources (1)
- FDA UDI 1ed7074b-0a10-44b7-b076-36976234fd36 33 fields · synced Jun 1, 2026