Catalog Number

-

Brand Name

Alegent

Version/Model Number

18081-Alegent

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

-

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

K003344,K003344

Product Code

BTI

Product Code Name

Compressor, air, portable

Public Device Record Key

136b1d12-45b4-45b7-93a6-be961475448d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10822383543557

Quantity per Package

6

Contains DI Package

00822383543550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-