Identity
- Trade Name
- Acosta Uro-Gard FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Uro-Gard Urinary Collection Bag FDA UDI
- Model / Reference
- 90-2003-001 FDA UDI
- Description
- Uro-Gard Urinary Collection Bag FDA UDI
Identifiers
- Catalog Number
- 90-2003-001 FDA UDI
- Primary DI / UDI-DI
- 00860012266807 FDA UDI
- FDA Product Code
- NNW 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
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-wearable adult urine collection bag, open-ended
Acosta Uro-Gard by Acosta Medical Group Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Acosta Medical Group Inc.
Sources (1)
- FDA UDI 1b5237a5-c7ba-4799-8a74-117fa9576225 34 fields · synced May 30, 2026