Identity
- Trade Name
- UltraviewSL FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- 91496 UVSL COMMAND MODULE - NELLCOR FDA UDI
- Model / Reference
- 91496 FDA UDI
- Description
- 91496 UVSL COMMAND MODULE - NELLCOR FDA UDI
Identifiers
- Catalog Number
- L-91496-N FDA UDI
- Primary DI / UDI-DI
- 10841522107788 FDA UDI
- 510(k) Number
- K103142 FDA UDI
- FDA Product Code
- DSI FDA UDIDXN FDA UDIFLL FDA UDIDQA FDA UDIDXG FDA UDIDSK FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.1130 FDA UDI880.2910 FDA UDI870.2700 FDA UDI870.1435 FDA UDI870.1110 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
Yes
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
Cleared under the same submission
K103142 also covers:
- TruLink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
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 048e3656-6bc2-45d8-b840-549aec51e001 37 fields · synced Jun 1, 2026