FDA.reportPublic FDA data

Tempo

Primary DI
10857425005724
Brand
Tempo
Company
Hemasource, Inc.
Model
SD50230BKA
Device description
Tempo Dual Head Stethoscope Assembled - Black
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LDEStethoscope, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDEStethoscope, ManualCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857425005724PackageGS1100In Commercial Distribution
00857425005727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085742500572410857425005724
00857425005727008574250057278574250057270857425005727

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical external stethoscopeA non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009046405
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00857425005956TempoICE6650CC2022-12-08
10857425005953TempoICE6650CC2022-12-08
00857425005727TempoSD50230BKA2022-12-08
00891153001811TempoSD4030BK2022-12-08
00891153001927TempoSD5030G2022-12-08
00891153001941TempoSD5030YA2022-12-08
00891153001958TempoSD5030R2022-12-08
00891153001965TempoSD5030O2022-12-08
00891153001989TempoSD5030BEA2022-12-08
10891153001818TempoSD4030BK2022-12-08
10891153001924TempoSD5030G2022-12-08
10891153001948TempoSD5030YA2022-12-08
10891153001955TempoSD5030R2022-12-08
10891153001962TempoSD5030O2022-12-08
10891153001986TempoSD5030BEA2022-12-08
00857425005635Select ChoiceGAU21022022-12-08
00891153001194Tempo22042022-12-08
00891153001200Tempo44042022-12-08
00891153001217Tempo33042022-12-08
00891153001361Tempo2204S2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536933507BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933514BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933521BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933538BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933569BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933576BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933583BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933590BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933606BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00197998470479Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470493Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470516Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470530Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470554Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470578Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00010939960184Foster & ThriveMCKESSON CORPORATIONLDE2024-06-18
00193489016416MedlineMEDLINE INDUSTRIES, INC.LDE2024-03-05
00057475506490BIOS DiagnosticsThermor LtdLDE2023-06-05
00057475507497BIOS DiagnosticsThermor LtdLDE2023-06-05
00057475508494BIOS DiagnosticsThermor LtdLDE2023-06-05
50080196171482MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
50080196716249MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
50080196779190MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
10885380067969CARDINAL HEALTHCardinal Health 200, LLCLDE2022-12-08
10885380067976CARDINAL HEALTHCardinal Health 200, LLCLDE2022-12-08
10885380067983CARDINAL HEALTHCardinal Health 200, LLCLDE2022-12-08
10653160278801CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLDE2022-01-02
10653160291510CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLDE2022-01-02
M3687111001LABTRONGF HEALTH PRODUCTS, INC.LDE2021-08-24
10885632287459MedichoiceOWENS & MINOR DISTRIBUTION, INC.LDE2020-12-14