Catalog Number

-

Brand Name

Spike

Version/Model Number

Spike

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

K981613,K981613

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

40ed1eed-ac60-4af3-9321-7412e1c16573

Public Version Date

August 15, 2018

Public Version Number

4

DI Record Publish Date

November 30, 2015

Package DI Number

10803622129374

Quantity per Package

20

Contains DI Package

00803622129377

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE