NA - FN51915N FILTER NDL 5MIC 19G x 1.5 NRFIT - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: FN51915N FILTER NDL 5MIC 19G x 1.5 NRFIT

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More Product Details

Catalog Number

339169

Brand Name

NA

Version/Model Number

339169

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Record Status

Public Device Record Key

bdb91e49-e8ac-442e-923d-82ca534c9807

Public Version Date

June 21, 2022

Public Version Number

3

DI Record Publish Date

July 30, 2018

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