B.BRAUN - SpaceStation with SpaceCom - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: SpaceStation with SpaceCom

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More Product Details

Catalog Number

8713142U

Brand Name

B.BRAUN

Version/Model Number

8713142U

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)

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

FRN

Product Code Name

Pump, infusion

Device Record Status

Public Device Record Key

f95bc124-05c6-45d3-bbc7-b6c9c9eff767

Public Version Date

February 09, 2022

Public Version Number

8

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