Identity
- Trade Name
- Truer Medical, Inc. FDA UDI
- Generic Name
- Electronic oesophageal stethoscope, single-use FDA UDI
- Device Name
- The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgical setting for monitoring temperature, as well as, heart and lung sounds of anesthetized patients. Inserted in the esophagus, the stethoscope provides an accurate measurement of core body temperature, as well as, transmitting clear heart and lung sounds to the anesthesiologist. FDA UDI
- Model / Reference
- ES 9000 FDA UDI
- Description
- The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgical setting for monitoring temperature, as well as, heart and lung sounds of anesthetized patients. Inserted in the esophagus, the stethoscope provides an accurate measurement of core body temperature, as well as, transmitting clear heart and lung sounds to the anesthesiologist. FDA UDI
Identifiers
- Catalog Number
- ES 9000 FDA UDI
- Primary DI / UDI-DI
- 00859290006076 FDA UDI
- 510(k) Number
- K092716 FDA UDI
- FDA Product Code
- BZT FDA UDI
- GMDN Term
- Electronic oesophageal stethoscope, 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
No
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: Electronic oesophageal stethoscope, single-use
Truer Medical, Inc. by Truer Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092716 also covers:
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER MEDICAL, INC.
- Truer Medical, Inc. — TRUER 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
- Truer Medical, Inc.
Sources (1)
- FDA UDI 733629e5-30f1-4e60-806f-45587cf4fe54 36 fields · synced May 31, 2026