INTROCAN SAFETY® - INTROCAN SAFETY FEP 20G, 1.1X25MM-US - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: INTROCAN SAFETY FEP 20G, 1.1X25MM-US

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More Product Details

Catalog Number

4252543-020

Brand Name

INTROCAN SAFETY®

Version/Model Number

4252543-020

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

DYB

Product Code Name

INTRODUCER, CATHETER

Device Record Status

Public Device Record Key

82857ad7-38de-45a8-b8d7-97bb7338349e

Public Version Date

June 10, 2022

Public Version Number

12

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

04046964398957

Quantity per Package

4

Contains DI Package

04046964398940

Package Discontinue Date

-

Package Status

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