Identity
- Trade Name
- SpotOn™ FDA UDI
- Generic Name
- Continuous electronic patient thermometer, line-powered FDA UDI
- Device Name
- 3M™ SpotOn™ Temperature Monitoring System 37000 FDA UDI
- Model / Reference
- 37000 FDA UDI
- Description
- 3M™ SpotOn™ Temperature Monitoring System 37000 FDA UDI
Identifiers
- Catalog Number
- 37000 FDA UDI
- Primary DI / UDI-DI
- 00608223370001 FDA UDI
- 510(k) Number
- K120412 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Continuous electronic patient thermometer, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
Yes
FDA UDI
Category: Continuous electronic patient thermometer, line-powered
SpotOn™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Continuous electronic patient thermometer, line-powered.
- CIRCA Temperature Monitoring System — CIRCA Scientific, Inc. · Class II
- CIRCA Temperature Monitoring System — CIRCA Scientific, Inc. · Class II
- SMARTFREEZE™ — Boston Scientific · Class II
- S-CATH Interconnect Cable — CIRCA Scientific, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Temperature Standard — CIRCA Scientific, Inc. · Class II
Cleared under the same submission
K120412 also covers:
- 3M™ — 3M COMPANY
- 3M™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- Bair Hugger™ — 3M COMPANY
- Bair Hugger™ — 3M COMPANY
- Bair Hugger™ — 3M COMPANY
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
- 3m Company
Sources (1)
- FDA UDI 3d14e5fc-8a3d-4ccd-b9c4-c4228040a327 36 fields · synced May 30, 2026