IV Administration Set - SAFEDAY IV ADMIN SET - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: SAFEDAY IV ADMIN SET

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More Product Details

Catalog Number

470199

Brand Name

IV Administration Set

Version/Model Number

470199

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 2021

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

6bcc99d8-2dc3-4319-824d-b500670c2c77

Public Version Date

December 27, 2021

Public Version Number

5

DI Record Publish Date

January 06, 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