SUPOR - 32 mm 5 Micron Syringe Filter - BAXTER CORPORATION ENGLEWOOD

Duns Number:078383477

Device Description: 32 mm 5 Micron Syringe Filter

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More Product Details

Catalog Number

H93824640

Brand Name

SUPOR

Version/Model Number

H93824640

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

FPB

Product Code Name

Filter, infusion line

Device Record Status

Public Device Record Key

958f623e-421e-47ef-8838-1d7df104985f

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

55413765482705

Quantity per Package

50

Contains DI Package

05413765482700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER CORPORATION ENGLEWOOD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 30