Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Bag Leg With Flip Valve 18 Inch Extension Tubing, Button Hook, 30 Inch Leg Strap Large Capacity Bag, Not Made With Natural Rubber Latex Vinyl 32oz (900ml) MediChoice FDA UDI
- Model / Reference
- SLB0032T FDA UDI
- Description
- Bag Leg With Flip Valve 18 Inch Extension Tubing, Button Hook, 30 Inch Leg Strap Large Capacity Bag, Not Made With Natural Rubber Latex Vinyl 32oz (900ml) MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632102127 FDA UDI
- FDA Product Code
- FAQ FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, open-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
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
MediChoice by Owens & Minor Distribution, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 3d7f85cc-591f-4a51-8812-c56fea55c384 34 fields · synced May 31, 2026