FDA.reportPublic FDA data

Truer Medical, Inc.

Primary DI
00859290006083
Brand
Truer Medical, Inc.
Company
TRUER MEDICAL, INC.
Model
ES 1200
Catalog number
ES 1200
Device description
The Truer Medical disposable Esophageal Stethoscope with TemperatureSensor 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 bodytemperature, as well as, transmitting clear heart and lung sounds to theanesthesiologist.
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K092716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092716000ESOPHAGEAL STETHOSCOPETruer Medical, Inc.2009-09-17BZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859290006080PackageGS125In Commercial Distribution
20859290006087PackageGS12In Commercial Distribution
30859290006084PackageGS15In Commercial Distribution
40859290006081PackageGS16In Commercial Distribution
00859290006083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085929000608010859290006080
2085929000608720859290006087
3085929000608430859290006084
4085929000608140859290006081
00859290006083008592900060838592900060830859290006083

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(714) 628-9785cpescador@truermedical.com
(714) 628-9785ctruitt@truermedical.com
(714) 628-9785ttruitt@truermedical.com

Regulatory Flags#

DUNS number
003530786
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859290006489Sharn by MarketlabSharn SSP-4002024-10-29
10859290006486Sharn by MarketlabSharn SSP-4002024-10-29
00859290006472HP to 3.5mm Phonojack Cable with Shrinkwrap70309703092024-01-16
00859290006465Truer Bougie Coiled905532023-09-22
10859290006462Truer Bougie Coiled905532023-09-22
00859290006441400 Series Right Angle Cable (80 cm)703232023-07-19
00859290006458400 Series Right Angle Cable (160 cm)703262023-07-19
00859290006359Pediatric Stylet90201902012022-06-30
00859290006342Adult Stylet90200902002022-06-30
00859290006434CO EX LINE 96'X.048'X112' M/M90116901162022-12-09
00859290006410Nasal Cannula 90413904132022-09-08
10859290006417Nasal Cannula 90413904132022-09-08
00859290006236Truer Bougie905522022-08-29
00859290006274Gas Sampling Line 120'x.048'x.108' M/F90101901012022-06-30
00859290006281Gas Sampling Line 120'x.040'x.112' M/M 90148901482022-06-30
00859290006298Gas Sampling Line 120'X.050'x.108' M/M90150901502022-06-30
00859290006304GAS SAMPLING LINE 120'x.050'x.108' M/F90151901512022-06-30
00859290006311GAS SAMPLING LINE 96'x.050'x.112' MM90156901562022-06-30
00859290006328GAS SAMPLING LINE 120' X .050' X .112' M/M90158901582022-06-30
00859290006267Gas Sampling Line 120 x .048 x .108 M/M CO-EX90100901002022-06-30

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Primary DI, Brand, Company table
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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