Catalog Number

BK-2085

Brand Name

Bolink™

Version/Model Number

BK-2085

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

6577f71d-627e-4ea2-80cb-61d0cebd6826

Public Version Date

June 11, 2019

Public Version Number

1

DI Record Publish Date

June 03, 2019

Package DI Number

10860136002425

Quantity per Package

30

Contains DI Package

00860136002435

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cse