FDA.reportPublic FDA data

HCS

Primary DI
00810132040696
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
HCS8004
Device description
Nurse Stethoscope, Black, Pre-assembled
Published
2023-04-07
Public version status
Update
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
10810132040693PackageGS1100In Commercial Distribution
00810132040696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204069310810132040693
00810132040696008101320406968101320406960810132040696

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical external stethoscope"A 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."

Regulatory Flags#

DUNS number
080220245
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
20810132043721HCS6606W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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