ClearView Nasal Mask and Capnography Bundle – Large Adult French Vanilla (pkg. o - ClearView Nasal Mask and Capnography Bundle – - ACCUTRON, INC.

Duns Number:088302096

Device Description: ClearView Nasal Mask and Capnography Bundle – Large Adult French Vanilla (pkg. of 12)

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More Product Details

Catalog Number

33034-14-CAP

Brand Name

ClearView Nasal Mask and Capnography Bundle – Large Adult French Vanilla (pkg. o

Version/Model Number

33034-14-CAP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 10, 2199

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"

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 Details

Product Code

KHA

Product Code Name

Mask, Scavenging

Device Record Status

Public Device Record Key

c21e6c39-a123-4f19-b849-32e400283c6a

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

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