Identity
- Trade Name
- IRMA Airway Adapter FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Device Name
- IRMA Airway Adapter Infant FDA UDI
- Model / Reference
- 106260 FDA UDI
- Description
- IRMA Airway Adapter Infant FDA UDI
Identifiers
- Catalog Number
- 106260 FDA UDI
- Primary DI / UDI-DI
- 17350046131603 FDA UDI
- FDA Product Code
- CBS FDA UDICBQ FDA UDICBR FDA UDINHP FDA UDICCK FDA UDINHQ FDA UDINHO FDA UDIBZA FDA UDI
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1620 FDA UDI868.1500 FDA UDI868.1700 FDA UDI868.1400 FDA UDI868.5810 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Straight/elbow breathing circuit connector, single-use
IRMA Airway Adapter by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Masimo Corporation
Sources (1)
- FDA UDI 5733ccdd-2bb7-486c-85a7-8384a3cf2084 34 fields · synced May 30, 2026