AccessGUDID - DEVICE: PAHI PAH-S1 Monoplace Hyperbaric Chamber (04719872000013)

GUDID

Device Identifier (DI) Information

Brand Name: PAHI PAH-S1 Monoplace Hyperbaric Chamber
Version or Model: PAH-S1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PAN-AMERICA HYPERBARICS INC.

Primary DI Number: 04719872000013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658755160 *Terms of Use

Device Description: The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment gas.

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?
12061	Hyperbaric chamber, stationary	A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBF	Chamber, Hyperbaric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021693	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
Device Size Text, specify: Max. Operating Pressure: 29.4 psig/3 ATA

Device Record Status

Public Device Record Key: 14bab18c-88a9-433e-8219-c4bde3a8e06c
Public Version Date: July 10, 2018
Public Version Number: 4
DI Record Publish Date: August 24, 2016