FDA.reportPublic FDA data

Gamow Bag

Primary DI
10856039006516
Brand
Gamow Bag
Company
HYPERBARIC TECHNOLOGIES, INC.
Model
15C37199
Device description
Hyperbaric Chamber
Published
2016-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBFChamber, Hyperbaric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001409000GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZERHyperbaric Technologies, Inc.2000-08-02CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856039006523PackageGS12In Commercial Distribution
10856039006530PackageGS13In Commercial Distribution
10856039006547PackageGS14In Commercial Distribution
10856039006516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085603900652310856039006523
1085603900653010856039006530
1085603900654710856039006547
1085603900651610856039006516

GMDN Terms#

Term, Definition table
TermDefinition
Hyperbaric chamber, portableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter21Inch

Contacts#

Phone, Email table
PhoneEmail
(877) 789-0123jdolin@oxyhealth.com

Regulatory Flags#

DUNS number
044725674
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10856039006011Vitaeris 32015C371792016-03-22
10856039006059Vitaeris 32015C372102016-10-31
10856039006110Respiro 27015C371822016-03-22
10856039006219Solace 21015C371762016-03-22
10856039006318Quamvis 32015T381452016-03-22
10856039006417Gamow Ultra-Lite15C381722016-03-22
10856039006615Quamvis 27015T381412016-03-22
10856039006714Quamvis Lite 32015C381542016-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850052737016Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737023Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737030Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737047Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737054Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737061Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
G625R8003403Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2026-08-27
00860006478988HMS-5000-6-MINI-QUADROHyperbaric Modular Systems Inc.CBF2026-05-05
08906124945116TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124945123TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124944713TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-02-12
G625R8003410Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-08-20
00850011262016PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2025-07-14
00860006478919HMS-5000Hyperbaric Modular Systems Inc.CBF2025-06-16
G625R800340Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-06-02
08906124943051TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
G623430US Hyperbaric NetworkUS Hyperbaric Network LLCCBF2025-05-02
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCCBF2024-11-21
08906124941477TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-09-03
00852834007003Newtowne Tent ChamberTYPHOON WATER WARES LTDCBF2024-05-28
B878430F0RevitalairOXAVITA S.R.L.CBF2024-01-19
08906124940012TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2023-09-29
00850011262009PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2023-08-07
00860006478940HMS-2000 Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478964HMS-1000Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478926HMS-4000Hyperbaric Modular Systems Inc.CBF2023-08-01
00860006478902HMS-5000-COMPACT-QUADROHyperbaric Modular Systems Inc.CBF2022-10-31
00852678007078Perry BaromedicalPERRY BAROMEDICAL CORPORATIONCBF2022-08-31