Catalog Number

311135

Brand Name

Lynn Medical - Ambulatory Kit

Version/Model Number

311135

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

fc99f132-555e-47cd-bb08-831c44048a69

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 24, 2018

Package DI Number

10851491007477

Quantity per Package

50

Contains DI Package

00851491007470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS