AccessGUDID - DEVICE: Perry Sigma Monoplace (00852678007092)

GUDID

Device Identifier (DI) Information

Brand Name: Perry Sigma Monoplace
Version or Model: Sigma 36 w/Undercarriage
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PERRY BAROMEDICAL CORPORATION

Primary DI Number: 00852678007092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 616251443 *Terms of Use

Device Description: HYPERBARIC SYSTEM, 36" MONOPLACE CHAMBER WITH UNDERCARRIAGE

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 [?]
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: 2600 Pound
Height: 68.45 Inch
Length: 105 Inch
Width: 42 Inch

Device Record Status

Public Device Record Key: 8afe7136-3a3f-4bfa-948e-6bb14e2553e6
Public Version Date: October 28, 2024
Public Version Number: 3
DI Record Publish Date: March 01, 2018