Perfect Fit - FastTrack Effort Pack, Pediatric - DYMEDIX DIAGNOSTICS, INC.

Duns Number:079976463

Device Description: FastTrack Effort Pack, Pediatric

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More Product Details

Catalog Number

-

Brand Name

Perfect Fit

Version/Model Number

11-44000-3002

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

-

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

-

FDA Premarket Submission

K040605,K040605,K040605

Product Code Details

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Device Record Status

Public Device Record Key

4ce3ee69-38e8-4319-b281-8e0530ef637e

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 05, 2018

Additional Identifiers

Package DI Number

00817377022135

Quantity per Package

40

Contains DI Package

00817377022104

Package Discontinue Date

-

Package Status

In Commercial Distribution

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