Extension Set - EXTENSION SET, 52 IN. - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: EXTENSION SET, 52 IN.

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More Product Details

Catalog Number

490480

Brand Name

Extension Set

Version/Model Number

490480

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2020

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

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

3f223614-562d-4fda-8955-a964bda74b6d

Public Version Date

October 23, 2020

Public Version Number

3

DI Record Publish Date

February 11, 2017

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