Catalog Number

-

Brand Name

OCEAN

Version/Model Number

2002-040

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

K043582,K043582

Product Code

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

61ba2e4f-387b-4046-ad2f-c4e5b8e90d4b

Public Version Date

October 15, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

20650862100345

Quantity per Package

6

Contains DI Package

00650862100341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-