AccessGUDID - DEVICE: HMS-2000 (00860006478940)

GUDID

Device Identifier (DI) Information

Brand Name: HMS-2000
Version or Model: HMS-2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hyperbaric Modular Systems Inc.

Primary DI Number: 00860006478940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831644005 *Terms of Use

Device Description: The HMS-2000 is a Class A, single compartment pressure vessel for human occupancy (PVHO) that is oriented in a vertical cylindrical geometry. The HMS-2000 hyperbaric chamber family of products is designed with non-dedicated seating, providing flexibility in managing seating arrangements. The diameter of the HMS-2000 varies in size; thereby enabling the ability to increase the patient capacity from three (3) to four (4) seated patients. An extension nozzle is attached to the chamber hull which provides the unique capability to treat one (1) patient in the supine versus seated position. The maximum allowable working pressure is three (3) Atmospheres Absolute (ATA) (~29.4psi). The control and operation of the HMS-2000 is performed from a hull mounted control console. The HMS-2000 multiplace hyperbaric chamber is designed, fabricated, and tested in compliance with the following FDA consensus standards: the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1) and the National Fire Protection Agency (NFPA) 99, Health Care Facilities.

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 [?]
K011866	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
No Device Sizes

Device Record Status

Public Device Record Key: f077a422-784a-4c08-832a-6d52cae7ea9a
Public Version Date: August 10, 2023
Public Version Number: 1
DI Record Publish Date: August 02, 2023