Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- COVERED BAG,DRAIN,ANTI-REFLUX TOW,2000ML FDA UDI
- Model / Reference
- UROECLIPSE FDA UDI
- Description
- COVERED BAG,DRAIN,ANTI-REFLUX TOW,2000ML FDA UDI
Identifiers
- Catalog Number
- UROECLIPSE FDA UDI
- Primary DI / UDI-DI
- 10884389941195 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, open-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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-wearable adult urine collection bag, open-ended
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-wearable adult urine collection bag, open-ended.
- RUSCH — TELEFLEX INCORPORATED · Class II
- AMSure® Urinary Drainage Bag — AMSINO INTERNATIONAL, INC. · Class II
- SteriGear — Sterigear, LLC · Class II
- MedPride — SHIELD-LINE, LLC · Class II
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18" — UROCARE PRODUCTS, INC. · Class I
- Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18" — UROCARE PRODUCTS, INC. · Class II
- Conveen Standard — Coloplast A/S · Class I
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" — UROCARE PRODUCTS, INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 38d71aac-1102-4695-9b4a-72854623ab45 35 fields · synced Jun 8, 2026