Identity
- Trade Name
- Empty IV Bag 500mL FDA UDI
- Generic Name
- Parenteral/enteral solution bag FDA UDI
- Model / Reference
- 099731320000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853620005197 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Parenteral/enteral solution bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 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
Category: Parenteral/enteral solution bag
Empty IV Bag 500mL by Merit Pharmaceutical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Parenteral/enteral solution bag.
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- Monoject — Cardinalhealth · Class II
- WalkMed® — WalkMed Technologies, LLC · Class I
- WalkMed® — WalkMed Technologies, LLC · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Merit Pharmaceutical
Sources (1)
- FDA UDI b1971187-0918-4d70-a3f5-84dc1cd1c335 33 fields · synced Jun 1, 2026