AccessGUDID - DEVICE: Newtowne Hyperbarics (00865439000232)

GUDID

Device Identifier (DI) Information

Brand Name: Newtowne Hyperbarics
Version or Model: Seal 24
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TYPHOON WATER WARES LTD

Primary DI Number: 00865439000232
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 361527229 *Terms of Use

Device Description: Seal model, 24" diameter, portable hyperbaric chamber.

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?
61959	Hyperbaric chamber, portable	A non-powered, portable device consisting of a large bag intended to contain a patient and to be inflated above ambient atmospheric pressure for the treatment of acute mountain sickness. The bag is inflated using a foot pump or air compressor, the internal pressure being controlled by an inlet/deflation valve; it is not intended to be used with enriched oxygen. The device is typically used by mountain climbers and athletes who train at high elevation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBF	Chamber, Hyperbaric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051759	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
Special Storage Condition, Specify: Away from sources of heat and chemicals.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 24 Inch
Length: 89 Inch

Device Record Status

Public Device Record Key: 41a576e8-e046-49d2-9787-f0e7ee90d34c
Public Version Date: January 15, 2019
Public Version Number: 4
DI Record Publish Date: April 30, 2016