FDA.reportPublic FDA data

Mon-a-Therm

Primary DI
10884521820890
Brand
Mon-a-Therm
Company
Covidien LP
Model
90041
Device description
Esophageal Stethoscope with Temperature Sensor 400TM
Published
2023-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZTSTETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZTStethoscope, Esophageal, With Electrical ConductorsAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251025000
K811862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251025000Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)Covidien, LLC2025-12-29BZT
K811862000HI-LO TEMP ESOPHAGEAL STETHOSCOPEMallinckrodt Critical Care1981-07-10BZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521820897PackageGS125In Commercial Distribution
30884521820894PackageGS12In Commercial Distribution
10884521820890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182089720884521820897
3088452182089430884521820894
1088452182089010884521820890

GMDN Terms#

Term, Definition table
TermDefinition
Electronic oesophageal stethoscope, single-useAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09
10884521837126ILLUMISITEILS-1000-CS2024-08-09
10884521837133ILLUMISITEILS-1000-CS2024-08-09
10884521837140ILLUMISITEILS-1000-CS2024-08-09
10884521837157ILLUMISITEILS-1000-CS2024-08-09
10884521842915ILLUMISITEILS-1000-CS2024-08-09
10884521837096ILLUMISITEILS-1000-CS2023-09-17
10884521199996superDimensionAAS00161-20RAAS00161-20R2016-09-24
10884521747425superDimensionPMB00667-012018-02-28
10884521747432superDimensionPMB00569-012018-02-28
10884521199989superDimensionAAS00161-202016-09-24
10884521747418superDimensionILS-0001-FN2018-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756392334DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
50749756392339DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
00817499020101LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020286LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020293LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020309LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020316NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020323NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020330NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020347NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020361NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020378NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020385NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020108LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020283LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020290LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020306LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020313NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020320NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020337NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020344NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020368NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020375NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020382NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10884521820906Mon-a-ThermCovidien LPBZT2023-05-29
10884521820913Mon-a-ThermCovidien LPBZT2023-05-29
10884521820920Mon-a-ThermCovidien LPBZT2023-05-29
30884521820894Mon-a-ThermCovidien LPBZT2023-05-29
20884521820903Mon-a-ThermCovidien LPBZT2023-05-29
30884521820917Mon-a-ThermCovidien LPBZT2023-05-29