Nox T3® Recorder - Nox Medical ehf.

Duns Number:365741462

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More Product Details

Catalog Number

561110

Brand Name

Nox T3® Recorder

Version/Model Number

NOX-ASDB1US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K082113

Product Code Details

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Device Record Status

Public Device Record Key

e2a6d453-aecc-4c32-9ead-153ed5657c80

Public Version Date

October 26, 2020

Public Version Number

3

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