Female - Female Adapter - "MR Female to Female - BAYER MEDICAL CARE INC.

Duns Number:058716649

Device Description: "MR Female to Female Adapter(KIT,ADAPTER,FEMALE-FEMALE LUER,MRI,MC,JA)(84194921)"

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More Product Details

Catalog Number

FFA 50

Brand Name

Female - Female Adapter

Version/Model Number

FFA 50

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980417,K980417

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

e8f0df88-1257-4d78-b945-0c978c1e03cf

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10616258007271

Quantity per Package

50

Contains DI Package

00616258007274

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-

"BAYER MEDICAL CARE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 360