15.5F X 28CM JET FLOW PRE-CURVED LT CATHETER - JET MEDICAL, INC.

Duns Number:079506014

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More Product Details

Catalog Number

JT021552801

Brand Name

15.5F X 28CM JET FLOW PRE-CURVED LT CATHETER

Version/Model Number

JT021552801

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

MPB

Product Code Name

Catheter, Hemodialysis, Non-Implanted

Device Record Status

Public Device Record Key

a09998c3-6c5e-48c4-be2b-0292a5deedf3

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

July 20, 2015

Additional Identifiers

Package DI Number

50810988020069

Quantity per Package

5

Contains DI Package

00810988020064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"JET MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 63