Catalog Number

68448

Brand Name

Atom Phototherapy Analyzer Ⅱ

Version/Model Number

68448

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJQ

Product Code Name

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Public Device Record Key

f1902d15-4d1b-4725-b62c-9cfdad1a5e6c

Public Version Date

January 29, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-