GIBECK - ISO GARD HEPA LIGHT - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: ISO GARD HEPA LIGHT

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More Product Details

Catalog Number

28012

Brand Name

GIBECK

Version/Model Number

IPN044092

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

K954828,K954828,K954828

Product Code Details

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Device Record Status

Public Device Record Key

8188aa5f-8f9a-4e03-858b-06c229f17561

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

24026704348088

Quantity per Package

20

Contains DI Package

04026704348084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26