13F X 17.5CM JET FLOW ST CATHETER - JET MEDICAL, INC.

Duns Number:079506014

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More Product Details

Catalog Number

JT031301751

Brand Name

13F X 17.5CM JET FLOW ST CATHETER

Version/Model Number

JT031301751

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2019

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

7aa0ad59-ed52-410c-b8e5-78621de41f81

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

July 20, 2015

Additional Identifiers

Package DI Number

50810988020274

Quantity per Package

5

Contains DI Package

00810988020279

Package Discontinue Date

August 26, 2019

Package Status

Not 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