Catalog Number

1085

Brand Name

Bolink(TM)

Version/Model Number

1085

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

K170555,K170555,K170555

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

101feabe-07fd-4450-be32-5331f3555058

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

January 19, 2018

Package DI Number

10867622000408

Quantity per Package

30

Contains DI Package

00867622000401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton