Nox RIP Starter Kit E, M - Nox Medical ehf.

Duns Number:365741462

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More Product Details

Catalog Number

558011

Brand Name

Nox RIP Starter Kit E, M

Version/Model Number

NOX-EMBA1KIT2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

decbb0ee-6530-493e-91df-b903083f2ca8

Public Version Date

April 14, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOX MEDICAL EHF." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 58