Identity
- Trade Name
- Level 1 FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Model / Reference
- STS-205 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30695085000192 FDA UDI
- 510(k) Number
- K864195 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- General-purpose patient temperature probe, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose patient temperature probe, single-use
Level 1 by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K864195 also covers:
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Level 1 — ICU MEDICAL, INC.
- Mindray — ICU MEDICAL, 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
- Icu Medical, Inc.
Sources (1)
- FDA UDI f9d3f647-36ab-48a0-8837-c8087456e87a 33 fields · synced May 30, 2026