Checkmate IV Administration Set 123in (312 cm) - QUEST MEDICAL INC

Duns Number:041810693

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More Product Details

Catalog Number

9652

Brand Name

Checkmate IV Administration Set 123in (312 cm)

Version/Model Number

9652

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 31, 2023

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"

-

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

0bac5167-28b8-4d70-910b-a8a584e98fd1

Public Version Date

March 29, 2021

Public Version Number

4

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

20634624096527

Quantity per Package

48

Contains DI Package

00634624096523

Package Discontinue Date

February 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipper

"QUEST MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 168
U Unclassified 8