UNIVERSAL FLEX2® - UNIVERSAL FLEX2 CIRCUIT - King Systems Corporation

Duns Number:009299017

Device Description: UNIVERSAL FLEX2 CIRCUIT

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More Product Details

Catalog Number

KNCF3116-61Z

Brand Name

UNIVERSAL FLEX2®

Version/Model Number

KNCF3116-61Z

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

CAI

Product Code Name

Circuit, breathing (w connector, adaptor, y piece)

Device Record Status

Public Device Record Key

62acf662-19cd-41ee-a08c-cf49dbd78480

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

April 17, 2019

Additional Identifiers

Package DI Number

00612649213828

Quantity per Package

40

Contains DI Package

00612649213835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"KING SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 717
2 A medical device with a moderate to high risk that requires special controls. 41