Identity
- Trade Name
- sourcemark FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- 18 French Esophageal Stethoscope with 400 Series Thermistor Temperature Sensor- Sterile FDA UDI
- Model / Reference
- SM18400ES FDA UDI
- Description
- 18 French Esophageal Stethoscope with 400 Series Thermistor Temperature Sensor- Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00897392002596 FDA UDI
- 510(k) Number
- K111050 FDA UDI
- FDA Product Code
- BZT FDA UDI
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1920 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
Yes
FDA UDI
Category: General-purpose patient temperature probe, single-use
sourcemark by Sourcemark, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose patient temperature probe, single-use.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Launch — SHENZHEN LAUNCH ELECTRICAL CO., LTD · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Level 1 — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K111050 also covers:
- SourceMark — SOURCEMARK, LLC.
- Sourcemark — SOURCEMARK, LLC.
- Sourcemark — SOURCEMARK, LLC.
- sourcemark — SOURCEMARK, LLC.
- sourcemark — SOURCEMARK, LLC.
- sourcemark — SOURCEMARK, LLC.
- Starboard Temperature Probes — Starboard Medical, Inc.
- Starboard Temperature Probes — Starboard Medical, Inc.
- Starboard Temperature Probes — Starboard Medical, Inc.
- Starboard Temperature Probes — Starboard Medical, Inc.
- Starboard Temperature Probes — Starboard Medical, Inc.
- Starboard Temperature Probes — Starboard 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sourcemark, Llc.
Sources (1)
- FDA UDI eca8a72a-b479-41d9-b95d-0efc1a27015c 34 fields · synced May 30, 2026