AccessGUDID - DEVICE: PAHI VersalVent (04719872000006)

GUDID

Device Identifier (DI) Information

Brand Name: PAHI VersalVent
Version or Model: Model V1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PAN-AMERICA HYPERBARICS INC.

Primary DI Number: 04719872000006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658755160 *Terms of Use

Device Description: The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when placed inside a monoplace hyperbaric chamber for prescribed therapy.

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):	Yes
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?
41148	Portable pneumatic ventilator	A pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, Continuous, Facility Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122560	000

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
Height: 241.3 Millimeter
Width: 203.2 Millimeter
Length: 304.8 Millimeter

Device Record Status

Public Device Record Key: 8607f4b5-4fa4-49dc-88a5-360fe9796e9b
Public Version Date: July 10, 2018
Public Version Number: 4
DI Record Publish Date: October 10, 2015