Catalog Number

12006-000-0010

Brand Name

AP133-01 - BLOOD SET WITH 2 NON-VENTED SPIKES, 200 FILTER AND NEEDLESS Y-SITE

Version/Model Number

12006-000-0010

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"

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

K123049,K123049

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

f67ba666-8dc4-40df-983a-40a04a0d2648

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Package DI Number

27290109159250

Quantity per Package

20

Contains DI Package

17290109159253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box