FDA.reportPublic FDA data

Stethoscope

Primary DI
00786511464134
Brand
Stethoscope
Company
RASHMAN CORPORATION
Model
S125-HPK
Device description
Ultra-Sensitive Dual Head Stethoscope
Published
2022-12-05
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
00786511464134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786511464134007865114641347865114641340786511464134

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
078803608
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00786511077938StethoscopeS121-AQS2022-12-06
00786511249236StethoscopeS120-BLK2022-12-06
00786511249243StethoscopeS120-ROY2022-12-06
00786511249250StethoscopeS120-PUR2022-12-06
00786511249267StethoscopeS120-SAS2022-12-06
00786511462192StethoscopeS108-HPK2022-12-06
00786511559113StethoscopeS108-STE2022-12-06
00786511563851StethoscopeS121-BLK2022-12-06
00786511566463StethoscopeS108-P-HPK2022-12-06
00786511566470StethoscopeS108-I-HPK2022-12-06
00786511566913StethoscopeS108-CBL2022-12-06
00786511624958StethoscopeS108-P-BLK2022-12-06
00786511629106StethoscopeS108-I-BLK2022-12-06
00786511629113StethoscopeS108-BLK2022-12-06
00786511629274StethoscopeS106-BLK2022-12-06
00786511769116StethoscopeS108-NAV2022-12-06
00786511869113StethoscopeS108-ROY2022-12-06
00786511879112StethoscopeS108-TEA2022-12-06
00786511939113StethoscopeS108-PUR2022-12-06
00786511077839StethoscopeS126-AQS2022-12-05

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Primary DI, Brand, Company table
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