FDA.reportPublic FDA data

MDF®

Primary DI
06940211621189
Brand
MDF®
Company
MDF Instruments Medifriend Inc.
Model
MDF797RG11
Device description
ProCardial® CORE Stethoscope, Rose Gold, MDF11
Published
2019-08-01
Public version status
Update
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
06940211621189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06940211621189069402116211896940211621189

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
420328205
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06940211612583MDF®MDF797T042019-08-01
06940211612590MDF®MDF797T102019-08-01
06940211612606MDF®MDF797T112019-08-01
06940211612620MDF®MDF797T172019-08-01
06940211612637MDF®MDF777RT2019-08-01
06940211612644MDF®MDF777MG2019-08-01
06940211612651MDF®MDF777GX2019-08-01
06940211612668MDF®MDF777LE42019-08-01
06940211612675MDF®MDF777LE52019-08-01
06940211612682MDF®MDF777LE62019-08-01
06940211612699MDF®MDF777LE72019-08-01
06940211612736MDF®MDF777LE82019-08-01
06940211612743MDF®MDF777LE92019-08-01
06940211612750MDF®MDF777SK2019-08-01
06940211612767MDF®MDF777DTLE12019-08-01
06940211612774MDF®MDF777DTLE22019-08-01
06940211612781MDF®MDF777DTLE42019-08-01
06940211612804MDF®MDF777DTLE52019-08-01
06940211612897MDF®MDF797DDRG112019-08-01
06940211612903MDF®MDF777SL2019-08-01

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