SUPOR - 25 mm 1.2 Micron Syringe Filter - BAXTER CORPORATION ENGLEWOOD

Duns Number:078383477

Device Description: 25 mm 1.2 Micron Syringe Filter

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More Product Details

Catalog Number

H93821012

Brand Name

SUPOR

Version/Model Number

H93821012

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

2c21d9d9-b676-4889-bf71-0454c8521c2d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

55413765482668

Quantity per Package

50

Contains DI Package

05413765482663

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