3F X 55CM SINGLE LUMEN POWER PICC - 3F X 55CM SINGLE LUMEN JET POWER INJECTABLE PICC - JET MEDICAL, INC.

Duns Number:079506014

Device Description: 3F X 55CM SINGLE LUMEN JET POWER INJECTABLE PICC

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More Product Details

Catalog Number

JT05035501

Brand Name

3F X 55CM SINGLE LUMEN POWER PICC

Version/Model Number

JT05035501

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

LJS

Product Code Name

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Device Record Status

Public Device Record Key

939ac5a8-0d6a-4d04-b170-62d26596d6fb

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

July 20, 2015

Additional Identifiers

Package DI Number

50810988020588

Quantity per Package

10

Contains DI Package

00810988020583

Package Discontinue Date

May 14, 2018

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