FDA.reportPublic FDA data

G5®

Primary DI
11201702212986
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 ca
Published
2017-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYIPercussor, Powered-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
11201702212986PackageGS11In Commercial Distribution
00746980000073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1120170221298611201702212986
00746980000073007469800000737469800000730746980000073

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Weight3Pound

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00007469820231G5®VIBRACARE ZX1VIBRACARE ZX12023-10-25
00746980002022G5®GK120BGK120B2017-05-12
00746980002268G5®ME 610 24 VME 610 24 V2017-06-12
00746980002640G5®VM 240 WDVM 240 WD2017-07-21
00746980002718G5®ME 610 240 VME 610 240 V2017-07-21
00746980000356G5FF24BFF24B2020-09-28
00746980002794G5®NC90NC902017-07-21
00746980001124G5®NC90NC902017-04-25
00746980001131G5®NC90NC902017-04-25
00746980001148G5®NC90NC902017-04-25
00746980001155G5®NC90NC902017-04-25
00746980002435G5®NC90NC902017-06-12
00746980002466G5®NC90NC902017-06-12
00746980002473G5®NC90NC902017-07-21
00746980002510G5®NC90NC902017-07-21
00746980002534G5®NC90NC902017-07-21
00746980002541G5®NC90NC902017-07-21
00746980002565G5®NC90NC902017-07-21
00746980002619G5®NC90NC902017-07-21
00746980002626G5®NC90NC902017-07-21

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