Identity
- Trade Name
- AirLife™ FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated FDA UDI
- Model / Reference
- 10604-855 FDA UDI
- Description
- Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated FDA UDI
Identifiers
- Catalog Number
- 10604-855 FDA UDI
- Primary DI / UDI-DI
- 10889483572818 FDA UDI
- 510(k) Number
- K993833 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
Yes
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
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- 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
K993833 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 a3a19586-2d4b-4440-bd48-2977f376f67b 36 fields · synced Jun 8, 2026