Identity
- Trade Name
- UltraviewSL FDA UDI
- Generic Name
- Patient monitoring system module, multiple-gas FDA UDI
- Device Name
- UVSL MULTIGAS ANALYZER, DUAL AGENT ID, LOANER FDA UDI
- Model / Reference
- 91518 FDA UDI
- Description
- UVSL MULTIGAS ANALYZER, DUAL AGENT ID, LOANER FDA UDI
Identifiers
- Catalog Number
- L-91518-A FDA UDI
- Primary DI / UDI-DI
- 10841522107795 FDA UDI
- 510(k) Number
- K053599 FDA UDI
- FDA Product Code
- CBR FDA UDI
- GMDN Term
- Patient monitoring system module, multiple-gas FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1700 FDA UDI
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
UltraviewSL by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 5b24f4eb-2913-4568-a557-f74a04705039 37 fields · synced Jun 1, 2026