FDA.reportPublic FDA data

MedSource Sprague Stethoscope

Primary DI
00816703028483
Brand
MedSource Sprague Stethoscope
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-STBLU
Catalog number
Not Applicable
Device description
Sprague Stethoscope, Blue
Published
2021-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00816703028483PackageGS150In Commercial Distribution
00816703028476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703028483008167030284838167030284830816703028483
00816703028476008167030284768167030284760816703028476

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
041674552
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
00816703025475MedSource Emesis BagMS-17360-RCSNot Applicable2021-05-10
00816703026526MedSource Airway DevicesMS-23908-RCSNot Applicable2021-05-18
00816703027172MedSource Traction SplintMS-TLS-3-RCSNot Applicable2021-08-16
00816703020838MedSource PRN, Male Luer PrositeMS-830112016-06-30
00816703021118MedSource NP Needle Free ConnectorMS-899792016-06-30
00840155421042Nasopharyngeal Airway1011-450002025-07-15
00840155401419MedSource CathetersMS-87414Not Applicable2023-01-09
00840155406179MedSource CathetersMS-87416Not Applicable2023-01-09
00840155413870MedSource CathetersMS-87420Not Applicable2023-01-09
00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
00840155413931MedSource CathetersMS-87424Not Applicable2023-01-09
00840155413962MedSource CathetersMS-874202Not Applicable2023-01-09
00840155413993MedSource Winged CathetersMS-84214WNot Applicable2023-01-30
00840155414020MedSource Winged CathetersMS-84216WNot Applicable2023-01-30
00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
00816703023129Elite CPR Face ShieldELITE-21105Not Applicable2021-04-20
00816703023143Elite CPR Face ShieldELITE-21106Not Applicable2021-04-20

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