VENTILATOR CIRCUIT - VENTILATOR CIRCUIT 30/CS - King Systems Corporation

Duns Number:009299017

Device Description: VENTILATOR CIRCUIT 30/CS

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More Product Details

Catalog Number

20740F-C

Brand Name

VENTILATOR CIRCUIT

Version/Model Number

20740F-C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2018

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

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Device Record Status

Public Device Record Key

4a7fc5da-80ea-401c-8048-7d58b7983b40

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

00612649102221

Quantity per Package

30

Contains DI Package

00612649185545

Package Discontinue Date

June 21, 2018

Package Status

Not 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