Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL FDA UDI
- Model / Reference
- DYND20302 FDA UDI
- Description
- TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL FDA UDI
Identifiers
- Catalog Number
- DYND20302 FDA UDI
- Primary DI / UDI-DI
- 10080196031801 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- Wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
Category: Wearable adult urine collection bag, open-ended
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wearable adult urine collection bag, open-ended.
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- Leg Bag — C. R. Bard, Inc. · Class I
- Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC. · Class II
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 13c9e63b-7637-4d9c-b5d4-933d266cf637 36 fields · synced Jun 8, 2026