Identity
- Trade Name
- AirLife™ FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- AirLife™ Isothermal Breathing Circuit 1.3 m (4.5') • Infant Respiratory Circuit Non-Heated FDA UDI
- Model / Reference
- 6800-503 FDA UDI
- Description
- AirLife™ Isothermal Breathing Circuit 1.3 m (4.5') • Infant Respiratory Circuit Non-Heated FDA UDI
Identifiers
- Catalog Number
- 6800-503 FDA UDI
- Primary DI / UDI-DI
- 10889483588123 FDA UDI
- 510(k) Number
- K915226 FDA UDI
- FDA Product Code
- BZE FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5270 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ventilator breathing circuit, single-use
AirLife™ by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, single-use.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- MEDIFLEX — Mediflex Medikal · Class IIa
- ALTECH — Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. · Class IIa
- Infant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Classic RT — Plastiflex Group NV · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K915226 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 393505a7-6711-4100-8a4d-2e3d498d21b1 36 fields · synced Jun 8, 2026