Catalog Number

311212

Brand Name

Lynn Medical - Ambulatory Kit

Version/Model Number

311212

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

60fab33e-bdb8-4581-bc09-e799f88e8984

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 10, 2018

Package DI Number

10851491007439

Quantity per Package

20

Contains DI Package

00851491007432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS