G5® - The G5 Neocussor is a gentle, quiet, - GENERAL PHYSIOTHERAPY INC

Duns Number:098639974

Device Description: The G5 Neocussor is a gentle, quiet, Directional-Stroking® model designed specifically for The G5 Neocussor is a gentle, quiet, Directional-Stroking® model designed specifically for neonatal applications. The lungs of a neonate frequently cannot perform the cough mechanism due to their premature condition. The G5 Neocussor provides a soothing, precise treatment to help loosen, and help mobilize secretion build-up in neonates. It is small enough to fit inside infant environmental chambers; is powered by a single "C" cell replaceable battery, and weighs less than five ounces. Comes with two (2) Directional-Stroking disposable applicators and one vibration applicator.Unit Advantages: Soft rubber end cushions unit in the event of a fall. Red Arrow indicates the direction of fluid movement. Comes with three different applicators.

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More Product Details

Catalog Number

NC90

Brand Name

G5®

Version/Model Number

NC90

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 14, 2020

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)

-

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

BYI

Product Code Name

Percussor, Powered-Electric

Device Record Status

Public Device Record Key

fc4bc49f-8fa6-404d-959f-546dc4f5b191

Public Version Date

April 15, 2020

Public Version Number

3

DI Record Publish Date

August 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENERAL PHYSIOTHERAPY INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 355