Catalog Number

LCA184

Brand Name

Aero-Med

Version/Model Number

LCA184

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2020

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

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

c2476c78-1d3b-48a7-87ca-e9a89e7621b0

Public Version Date

February 21, 2020

Public Version Number

3

DI Record Publish Date

September 13, 2019

Package DI Number

50810010892169

Quantity per Package

24

Contains DI Package

00810010892164

Package Discontinue Date

February 21, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE