FDA.reportPublic FDA data

Truer Medical, Inc.

Primary DI
00859290006137
Brand
Truer Medical, Inc.
Company
TRUER MEDICAL, INC.
Model
SSP 400
Catalog number
SSP 400
Device description
The Truer Medical Skin Temperature Sensor is designed for monitoringa patient’s skin surface temperature during surgical procedures,postoperative recovery, or whenever a clinician needs to accuratelyassess patient skin temperature. The Truer Medical, Inc. Skin Sensorhas reflective silver material on one side to insulate the sensor fromheat generated by operating room lights or heat lamps.
Published
2016-08-04
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
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101244000SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBETruer Medical, Inc.2010-11-18FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859290006134PackageGS150In Commercial Distribution
20859290006131PackageGS14In Commercial Distribution
30859290006138PackageGS110In Commercial Distribution
40859290006135PackageGS126In Commercial Distribution
50859290006132PackageGS12In Commercial Distribution
60859290006139PackageGS16In Commercial Distribution
00859290006137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085929000613410859290006134
2085929000613120859290006131
3085929000613830859290006138
4085929000613540859290006135
5085929000613250859290006132
6085929000613960859290006139
00859290006137008592900061378592900061370859290006137

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Contacts#

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