Catalog Number

450431

Brand Name

MiniCollect

Version/Model Number

450431

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GIO

Product Code Name

TUBE, COLLECTION, CAPILLARY BLOOD

Public Device Record Key

ee95eb0e-99b5-4906-92c8-cdc26288ff6a

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

49120017570996

Quantity per Package

10

Contains DI Package

39120017570999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-