MDF® - ProCardial ERA® Stethoscope, MDF04 - MDF Instruments Medifriend Inc.

Duns Number:420328205

Device Description: ProCardial ERA® Stethoscope, MDF04

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More Product Details

Catalog Number

-

Brand Name

MDF®

Version/Model Number

MDF797XB04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LDE

Product Code Name

Stethoscope, Manual

Device Record Status

Public Device Record Key

05ef9089-f33f-4113-8200-f2eab149e5ec

Public Version Date

August 09, 2019

Public Version Number

1

DI Record Publish Date

August 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MDF INSTRUMENTS MEDIFRIEND INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 245
2 A medical device with a moderate to high risk that requires special controls. 150