FDA.reportPublic FDA data

Acme

Primary DI
06975185470037
Brand
Acme
Company
Wenzhou Kangshun Medical Devices CO.,LTD
Model
KS-2045
Device description
DUAL STETHOSCOPE
Published
2025-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06975185470037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975185470037069751854700376975185470037

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
544394159
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975185470150Lightning012025-09-15
06975185470358Lightning012026-08-08
06975185470136Lightning012025-09-15
06975185470167Lightning012025-09-15
06975185470044konsunmedks-22032025-04-20
06975185470075konsunmedks-12222025-04-20
06975185470112konsunmedKS-22012025-04-20
06975185470068konsunmed012024-07-03
06975185470051bluejayBJ1202002024-06-09

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