FDA.reportPublic FDA data

Tempo

Primary DI
10891153001986
Brand
Tempo
Company
Hemasource, Inc.
Model
SD5030BEA
Device description
Tempo Dual Head Stethoscope Assembled - Blue
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
10891153001986PackageGS1100In Commercial Distribution
00891153001989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089115300198610891153001986
00891153001989008911530019898911530019890891153001989

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
10857425005724TempoSD50230BKA2022-12-08
10891153001818TempoSD4030BK2022-12-08
10891153001924TempoSD5030G2022-12-08
10891153001948TempoSD5030YA2022-12-08
10891153001955TempoSD5030R2022-12-08
10891153001962TempoSD5030O2022-12-08
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
00634782101848Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102098Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102104Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102111Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102128Adsoft™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
04053755207596GAMMA 3.2 VETHeine Optotechnik GmbH & Co. KGLDE2026-07-22
06972545090454JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
06972545090461JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
16972545090123JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
16972545090130JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
00199536933552BluelineTransparent Supply Solutions Ltd.LDE2026-06-15
00634782102258Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-06-02
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
00634782098384Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-03-30
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