FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216105614
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
STA400
Device description
STETHOSCOPE, SINGLE HEAD, RED TUBING, ALUMINUM BINAURAL, BLANK DIAPHRAGM, WHITE EARTIPS, 1EA/BG 100BG/CS
Published
2022-07-31
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
00840216105614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216105614008402161056148402161056140840216105614

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical stethoscopeA mechanical listening device designed for listening to sounds from the 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 users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119291ASP MEDICALINFHW-ASP2022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970784670222Rhino Rescuewenzhou dongfang medical instrument co.,ltdLDE2026-03-24
00197998470486Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470509Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470523Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470547Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470561Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470585Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00767056422018MabisD-M-S HOLDINGS, INC.LDE2025-12-29
06975185470136LightningWenzhou Kangshun Medical Devices CO.,LTDLDE2025-09-15
06975185470150LightningWenzhou Kangshun Medical Devices CO.,LTDLDE2025-09-15
06974546523160TealmedNingbo Tealmed Emergency Products Co., Ltd.LDE2025-07-21
04053755203048GAMMA 3.2Heine Optotechnik GmbH & Co. KGLDE2025-07-17
06974546523153TealmedNingbo Tealmed Emergency Products Co., Ltd.LDE2025-05-12
06975185470037AcmeWenzhou Kangshun Medical Devices CO.,LTDLDE2025-03-05
04030155004819Colorscop-duo stethoscope, pinkKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155004970Standard-Prestige stethoscope stainless steel, blackKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155005076Planet double stethoscope according to FassbenderKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155005168Ear tips, black, Ø 5,5 mm, PU: 10 pcs. W. white turned partsKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155011695Stethoscope double tube, black, length 60cmKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155019448Planet Air stethoscopeKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
10889483005378SunMedSUNMED, LLCLDE2023-08-01
00888277722388MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
00634782600402Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782600990Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601003Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601010Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601027Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601034Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601072Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601089Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11