AccessGUDID - DEVICE: G5 (00746980000356)

GUDID

Device Identifier (DI) Information

Brand Name: G5
Version or Model: FF24B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FF24B
Company Name: GENERAL PHYSIOTHERAPY INC

Primary DI Number: 00746980000356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098639974 *Terms of Use

Device Description: The G5 Flimm-Fighter Percussor is the optimum percussor for effective postural drainage at home. The Flimm-Fighter incorporates Directional-Stroking action that helps loosen congestive materials and then moves them into the upper airways, thus promoting airway clearance. The red arrow on the head of the Flimm-Fighter shows the user the direction that the loosened materials are moving inside the body. The ultra-light applicator head, weighing less than one pound, allows a patient to effortlessly receive or self-administer therapy, as it is designed for use with our self application pillow*. The continuously-variable speed range of 20 - 30 cycles per second ensures that patients receive safe, thorough treatment. Comes with applicators 250, 251, 253 & 234. A pediatric version is also available. Unit Advantages: Ideal for COPD, Cystic Fibrosis, Bronchiectasis, Chronic Bronchitis, Atelectasis, Asthma, and Bronchopulmonary Dysplasia patients needing postural drainage Extremely lightweight, the Flimm-Fighter handle weighs less than 1 pound Speed: 20 - 30 cycles per second Can be used with our self application kit* and the Vari-Tilt body positioner *Self Application Kit available separately.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36560	Hand-held electric massager	An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 12 Pound

Device Record Status

Public Device Record Key: 0692eb3d-feec-4974-8643-05e2c9f815d5
Public Version Date: October 06, 2020
Public Version Number: 1
DI Record Publish Date: September 28, 2020