Identity
- Trade Name
- IRMA™ CO2 FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Device Name
- IRMA™ CO2 FDA UDI
- Model / Reference
- 4748 FDA UDI
- Description
- IRMA™ CO2 FDA UDI
Identifiers
- Catalog Number
- 4748 FDA UDI
- Primary DI / UDI-DI
- 07350046131675 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Patient monitoring system module, carbon dioxide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
No
FDA UDI
Category: Patient monitoring system module, carbon dioxide
Irma™ Co2 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- single CO2 Module (Package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co. · 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 |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI ad55182a-f66c-4637-bdda-7c685b4af90c 34 fields · synced Jun 8, 2026