FDA.reportPublic FDA data

Tempheart

Primary DI
H29740091
Brand
Tempheart
Company
MEASUREMENT SPECIALTIES, INC.
Model
4009
Catalog number
060534
Device description
MEAS Tempheart® Shields
Published
2018-09-21
Public version status
New
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
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H29740091PrimaryHIBCC0
H29740090Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-899-9783medfeedback@te.com

Regulatory Flags#

DUNS number
029351079
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H29744640MEAS 4400 Series Temperature Probe44648615552016-07-01
H29744680MEAS 4400 Series Temperature Probe44688615572016-07-01
H297800106341408001 Series Foley Catheter Temperature Probe8001-063-4148001-063-4142016-07-01
H29744660MEAS 4400 Series Temperature Probe44668615562016-07-01
H297800106341608001 Series Foley Catheter Temperature Probe8001-063-4168001-063-4162016-07-01
H2974010Reusable GP Temperature Probe4018811012018-09-21
H29740100Extension Cable40100813202018-09-21
H29740121Mini Tempheart40120609852018-09-21
H2974020Reusable GP Temperature Probe4020811022018-09-21
H2974030Reusable Tubular Temperature Probe4030811032018-09-21
H2974060Reusable Tubular Temperature Probe4060811062018-09-21
H297409A0Reusable Skin Temperature Probe409A0812082018-09-21
H297409B0Reusable Skin Temperature Probe409B0812092018-09-21
H2974270Reusable Skin Temperature Probe4270811172018-09-21
H2977010Reusable GP Temperature Probe7018813002018-09-21
H2977290Reusable Skin Temperature Probe7290813122018-09-21
H29744910MEAS 4400 Series Temperature Probe44918615272016-07-01
H29744990MEAS 4400 Series Temperature Probe44998615522016-07-01
H2974499HD0MEAS 4400 Series Temperature Probe4499HD8615532016-07-01
H2974499RJ0MEAS 4400 Series Temperature Probe4499RJ861551TP2016-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23