Burette Set - BURETTE SET, 4 CARESITE LADS, STPCK 125" - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: BURETTE SET, 4 CARESITE LADS, STPCK 125"

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More Product Details

Catalog Number

490252

Brand Name

Burette Set

Version/Model Number

490252

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

FMG

Product Code Name

Stopcock, i.V. Set

Device Record Status

Public Device Record Key

97048440-ba8e-4d14-b3d0-61b22236bb9a

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

July 23, 2019

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