Catalog Number

400002005

Brand Name

aScope™ 2Flexible Intubation Scope

Version/Model Number

400002005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

6a5c55ad-beaa-46f9-8882-24e8e1c94803

Public Version Date

May 22, 2019

Public Version Number

3

DI Record Publish Date

January 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-