DEVICE: Mon-a-Therm (20884521031736)
Device Identifier (DI) Information
Mon-a-Therm
90043
In Commercial Distribution
Covidien LP
90043
In Commercial Distribution
Covidien LP
Esophageal Stethoscope with Temperature Sensor 400TM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44120 | Electronic oesophageal stethoscope, single-use |
An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZT | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K811862 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 24 French |
Device Record Status
06db4485-b7e7-4ba4-8565-4268852fdee7
June 24, 2025
8
September 24, 2016
June 24, 2025
8
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10884521031739 | 25 | 20884521031736 | In Commercial Distribution | PACK_OR_INNER_PACK | |
30884521031733 | 2 | 10884521031739 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com