Anesthesia IV Set - OUTLOOK SAFETY INFUSION SYSTEM 113 IN. - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: OUTLOOK SAFETY INFUSION SYSTEM 113 IN.

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More Product Details

Catalog Number

490479

Brand Name

Anesthesia IV Set

Version/Model Number

490479

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

FMG

Product Code Name

Stopcock, i.V. Set

Device Record Status

Public Device Record Key

7644c016-fd1a-407c-957b-7b5600458a70

Public Version Date

May 02, 2018

Public Version Number

3

DI Record Publish Date

January 14, 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