FDA.reportPublic FDA data

MDF®

Primary DI
06940211612590
Brand
MDF®
Company
MDF Instruments Medifriend Inc.
Model
MDF797T10
Device description
ProCardial® CORE Titanium Stethoscope, MDF10
Published
2019-08-01
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
06940211612590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06940211612590069402116125906940211612590

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06940211612583MDF®MDF797T042019-08-01
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
06940211612941MDF®MDF777LE122019-08-01

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Primary DI, Brand, Company table
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00634782102111Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102128Adsoft™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
04053755207596GAMMA 3.2 VETHeine Optotechnik GmbH & Co. KGLDE2026-07-22
06972545090454JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
06972545090461JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
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16972545090130JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
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00199536933606BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
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