DEVICE: Mon-a-Therm (20884521031736)

Device Identifier (DI) Information

Mon-a-Therm
90043
In Commercial Distribution

Covidien LP
20884521031736
GS1

1
058614483 *Terms of Use
Esophageal Stethoscope with Temperature Sensor 400TM
CLOSE

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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BZT STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K811862 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 24 French
CLOSE

Device Record Status

06db4485-b7e7-4ba4-8565-4268852fdee7
June 24, 2025
8
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
CLOSE