HIGH FLOW NASAL CANNULA LARGE - HIGH FLOW NASAL CANNULA LARGE - Intersurgical Incorporated

Duns Number:785952607

Device Description: HIGH FLOW NASAL CANNULA LARGE

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More Product Details

Catalog Number

-

Brand Name

HIGH FLOW NASAL CANNULA LARGE

Version/Model Number

7302000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

28b1f8f4-1be9-49e7-ab8a-31637b2ac65e

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

05030267159277

Quantity per Package

7

Contains DI Package

05030267157792

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101