Catalog Number

-

Brand Name

SMARTDOSE

Version/Model Number

CTOX-MN02

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

K090421,K090421

Product Code

NFB

Product Code Name

Conserver, Oxygen

Public Device Record Key

5854e7cd-c5d2-404e-9dd2-ec8164c7768b

Public Version Date

October 18, 2021

Public Version Number

5

DI Record Publish Date

June 28, 2016

Package DI Number

50822383296406

Quantity per Package

25

Contains DI Package

00814470020075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton