Identity
- Trade Name
- Inrad FDA UDI
- Generic Name
- Intravenous fluid bag spike FDA UDI
- Device Name
- IV Decanting Set FDA UDI
- Model / Reference
- 40050 FDA UDI
- Description
- IV Decanting Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817295020558 FDA UDI
- 510(k) Number
- K980587 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Intravenous fluid bag spike FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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: Intravenous fluid bag spike
Inrad by Inrad — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous fluid bag spike.
- HealthMark — CODAN US Corporation · Class II
- Codan — CODAN US Corporation · Class II
- Bag Decanter — REMINGTON MEDICAL, INC. · Class II
- Codan — CODAN US Corporation · Class II
- Procedure Products Adapters — PROCEDURE PRODUCTS, INC. · Class II
- CHR. HANSEN — CODAN US Corporation · Class II
- Bag Decanter — REMINGTON MEDICAL, INC. · Class II
- Codan — CODAN US Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inrad
Sources (1)
- FDA UDI a7b79d5a-f133-4a69-ac46-72d29e4bb9e0 35 fields · synced Jun 8, 2026