Infusomat® - UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV

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More Product Details

Catalog Number

363433

Brand Name

Infusomat®

Version/Model Number

363433

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

-

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

d5cb648a-86f8-4408-b9e0-e0a1dddaa574

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 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