Catalog Number

-

Brand Name

ASAHI Gaia Next 1

Version/Model Number

AH14R019P

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

c281a69b-0b2f-4f2e-8457-469d6f304805

Public Version Date

January 20, 2020

Public Version Number

1

DI Record Publish Date

January 10, 2020

Package DI Number

14547327136294

Quantity per Package

5

Contains DI Package

04547327136297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-