NA - HPRAMF MALE ROTATING FEML ADAP - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: HPRAMF MALE ROTATING FEML ADAP

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More Product Details

Catalog Number

622367

Brand Name

NA

Version/Model Number

622367

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2021

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

-

Product Code Details

Product Code

DXT

Product Code Name

INJECTOR AND SYRINGE, ANGIOGRAPHIC

Device Record Status

Public Device Record Key

bdb5f389-9afa-45f2-beb6-9c9c9948d3d2

Public Version Date

July 30, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B. BRAUN MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 277
U Unclassified 2