Identity
- Trade Name
- AMSure® Urinary Drainage Bag FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- AMSure® Urinary Drainage Bag Triangle Shape CONTENTS: One each 2000mL drainage bag equipped with: T-valve drainage outlet, Universal hanger, AMSecure® needleless sampling adapter, Anti-reflux vent FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® Urinary Drainage Bag Triangle Shape CONTENTS: One each 2000mL drainage bag equipped with: T-valve drainage outlet, Universal hanger, AMSecure® needleless sampling adapter, Anti-reflux vent FDA UDI
Identifiers
- Catalog Number
- AS332E FDA UDI
- Primary DI / UDI-DI
- 10704411002413 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
AMSure® Urinary Drainage Bag by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI 1de91a28-3bef-47ea-9946-5f74ab4d51d0 34 fields · synced Jun 6, 2026