Perfect Fit - ApneaTrak: Core Adult Disposable HSAT Kit - DYMEDIX DIAGNOSTICS, INC.

Duns Number:079976463

Device Description: ApneaTrak: Core Adult Disposable HSAT Kit

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More Product Details

Catalog Number

-

Brand Name

Perfect Fit

Version/Model Number

18-14250-0601

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

-

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

K040605

Product Code Details

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Device Record Status

Public Device Record Key

3d9a90ac-d2f0-481a-80c3-3b06dbcbe827

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYMEDIX DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 293