Nasal-Aire II - Nasal-Aire II Frame System - MD - Innomed Technologies Inc

Duns Number:103307950

Device Description: Nasal-Aire II Frame System - MD

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More Product Details

Catalog Number

NAT323

Brand Name

Nasal-Aire II

Version/Model Number

NAT323

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"

Yes

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

Public Device Record Key

47cce64f-7c9d-4f21-b8d9-26a315fba4bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

50833224000663

Quantity per Package

30

Contains DI Package

00833224000668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INNOMED TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 74