Identity
- Trade Name
- enFlow™ FDA UDI
- Generic Name
- Convection blood/fluid warmer set FDA UDI
- Device Name
- Controller Model 121 FDA UDI
- Model / Reference
- 980121EU FDA UDI
- Description
- Controller Model 121 FDA UDI
Identifiers
- Catalog Number
- 980121EU FDA UDI
- Primary DI / UDI-DI
- 10190752125803 FDA UDI
- 510(k) Number
- K130867 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Convection blood/fluid warmer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Convection blood/fluid warmer set
enFlow™ by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Convection blood/fluid warmer set.
- enFlow — VYAIRE MEDICAL, INC. · Class II
- enFlow™ — VYAIRE MEDICAL, INC. · Class II
- enFlow™ — Airlife, Inc. · Class II
- enFlow™ — Airlife, Inc. · Class II
Cleared under the same submission
K130867 also covers:
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
- Airlife, Inc.
Sources (1)
- FDA UDI eb155657-a03c-40e1-b0ef-153be1595f7d 37 fields · synced Jun 8, 2026