Tita Jet Light - Tita Jet Light PUR Kit HF with 8F x 750 mm - PFM MEDICAL INCORPORATED

Duns Number:097736867

Device Description: Tita Jet Light PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Tita Jet Light

Version/Model Number

616.362.2080-A

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

K072481,K072481

Product Code Details

Product Code

LJT

Product Code Name

Port & Catheter, Implanted, Subcutaneous, Intravascular

Device Record Status

Public Device Record Key

40dc4e0d-9b1c-495f-bb2d-329f45403f6c

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Additional Identifiers

Package DI Number

07640110981276

Quantity per Package

20

Contains DI Package

07640110987513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PFM MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 109