Identity
- Trade Name
- Drainage Bag FDA UDI
- Generic Name
- Bile collection bag FDA UDI
- Device Name
- Size: 600 ml FDA UDI
- Model / Reference
- 600-D FDA UDI
- Description
- Size: 600 ml FDA UDI
Identifiers
- Catalog Number
- 600-D FDA UDI
- Primary DI / UDI-DI
- 00813079020004 FDA UDI
- FDA Product Code
- EXF FDA UDI
- GMDN Term
- Bile collection bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 600 Milliliter FDA UDI
Category: Bile collection bag
Drainage Bag by Remington Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bile collection bag.
- Drainage Bag — Argon Medical Devices, Inc. · Class II
- Drainage Bag — Argon Medical Devices, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Remington Medical, Inc.
Sources (1)
- FDA UDI 722ddbdd-64e1-4b38-bdcd-2c3622950e0a 36 fields · synced Jun 8, 2026