Catalog Number

LCA850

Brand Name

Aero-Med

Version/Model Number

LCA850

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNK

Product Code Name

CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Public Device Record Key

2e6bcd1e-3689-4b14-af00-523f6a895efa

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

May 18, 2020

Package DI Number

50810010892800

Quantity per Package

10

Contains DI Package

00810010892805

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE