G5®
Basic Information
- Brand Name
- G5®
- Primary DI
- 00746980002015
- Version / Model
- NC90
- Catalog Number
- NC90
- Company Name
- GENERAL PHYSIOTHERAPY INC
- Labeler DUNS
- 098639974
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-12
- Public Version
- 3
- Public Version Date
- 2020-04-16
- Public Version Status
- Update
- Public Device Record Key
- 4ace1071-0676-4249-ad52-67572bd1af6c
- Distribution End Date
- 2020-04-15
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38083 | Neonatal chest percussor | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00746980002015 | GS1 |
Customer Contacts
- Phone
- 1-800-237-1832
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 3 | Pound |