Catalog Number

109536

Brand Name

Cartridge Blood Set

Version/Model Number

109536

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K070414,K070414

Product Code

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Public Device Record Key

1fb8c0c6-5598-4c7b-bf68-d46969f19bee

Public Version Date

October 11, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2015

Package DI Number

37332414085217

Quantity per Package

15

Contains DI Package

07332414085216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE