Identity
- Trade Name
- Ultraview SL® FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- KIT, DM3 UPDATE, V1.7 FDA UDI
- Model / Reference
- Ultraview FDA UDI
- Description
- KIT, DM3 UPDATE, V1.7 FDA UDI
Identifiers
- Catalog Number
- 040-1640-02 FDA UDI
- Primary DI / UDI-DI
- 10841522125997 FDA UDI
- 510(k) Number
- K093802 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple vital physiological parameter monitoring system, clinical
Ultraview SL® by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple vital physiological parameter monitoring system, clinical.
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Cleared under the same submission
K093802 also covers:
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
- Ultraview DM3 — ZOE MEDICAL INCORPORATED
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 9c264d7f-e5d2-465d-b03b-4abede364361 35 fields · synced Jun 6, 2026