FDA.report

G5®

Primary DI
00746980000288
Brand
G5®
Company
GENERAL PHYSIOTHERAPY INC
Model
NC90
Catalog number
NC90
Device description
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.
Published
2017-02-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BYIPercussor, Powered-Electric
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00746980000288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00746980000288007469800002887469800002880746980000288

GMDN Terms

TermDefinition
Neonatal chest percussorA hand-held battery-powered device (a percussor) intended to be operated by a healthcare professional to provide external vibrations to the chest wall of a neonate to help loosen bronchial mucus for expectoration through suctioning. It is small enough in physical dimension and weight to be operated inside an infant incubator and has a percussion head suitable for the thorax of a neonate. It is used to help loosen secretion build-up in the lungs of neonates who cannot perform the natural cough mechanism.

Device Sizes

TypeValueUnit
Weight3Pound
Weight7Pound

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-237-1832DNICKELSON@G5.COM

Regulatory Flags

DUNS number
098639974
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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