AccessGUDID - DEVICE: Summit to Sea (00866115000324)

GUDID

Device Identifier (DI) Information

Brand Name: Summit to Sea
Version or Model: The Grand Dive Hyperbaric Chamber
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUMMIT TO SEA, LLC

Primary DI Number: 00866115000324
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013140518 *Terms of Use

Device Description: No description.

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):	No
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 [?]
K072757	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: 915bc5e9-4e09-4b0a-86f9-8dcec79479d3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 27, 2017