Omnican® - OMNICAN 100 1 ML INSULIN U-100 30GX12 - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: OMNICAN 100 1 ML INSULIN U-100 30GX12

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More Product Details

Catalog Number

9151141US

Brand Name

Omnican®

Version/Model Number

9151141US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 2017

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

8c03db81-aed7-4e67-8f93-0b2f02d5c5a9

Public Version Date

March 16, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

04046963456825

Quantity per Package

24

Contains DI Package

04046963456818

Package Discontinue Date

October 20, 2017

Package Status

Not in Commercial Distribution

Package Type

Carton

"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