O2 Cannula, 50 Clear Adult, 7' Tubing - ACCUTRON, INC.

Duns Number:088302096

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More Product Details

Catalog Number

33030-50

Brand Name

O2 Cannula, 50 Clear Adult, 7' Tubing

Version/Model Number

33030-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 10, 2099

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Device Record Status

Public Device Record Key

df2c3c0b-307f-41bb-badb-3785b747d60b

Public Version Date

April 18, 2019

Public Version Number

1

DI Record Publish Date

April 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCUTRON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 344
2 A medical device with a moderate to high risk that requires special controls. 192