Catalog Number

CER-BD-15

Brand Name

Cervos Blood Draw Kit 15

Version/Model Number

CER-BD-15

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

-

Product Code

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

e969176d-1991-45a2-bfed-be577755766a

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Package DI Number

10850023741421

Quantity per Package

15

Contains DI Package

00850023741424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case