IV Administration Set - OUTLOOK SAFETY INF SYS Y-TYPE BLOOD SET - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: OUTLOOK SAFETY INF SYS Y-TYPE BLOOD SET

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

480232

Brand Name

IV Administration Set

Version/Model Number

480232

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

a0ee1477-d316-4b56-bfc8-c3e64ac64085

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

September 15, 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