Identity
- Trade Name
- ISA AX + Root FDA UDI
- Generic Name
- Patient monitoring system module rack FDA UDI
- Device Name
- ISA AX + Root and Mounting Bracket Kit ISA Sidestream Analyzer and Mounting Bracket for use with Root FDA UDI
- Model / Reference
- 4376 FDA UDI
- Description
- ISA AX + Root and Mounting Bracket Kit ISA Sidestream Analyzer and Mounting Bracket for use with Root FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997012904 FDA UDI
- GMDN Term
- Patient monitoring system module rack FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 rack
ISA AX + Root by Masimo Corporation — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI 0ae78b95-2581-4cad-b25e-fef4e32f94fe 35 fields · synced Jun 6, 2026