FDA.reportPublic FDA data

Newtowne Hyperbarics

Primary DI
00865439000263
Brand
Newtowne Hyperbarics
Company
TYPHOON WATER WARES LTD
Model
Class 7
Device description
Class 7 portable hyperbaric chamber.
Published
2016-04-30
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
K051759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051759000FLEXI-LITE, MODEL FL-V1.2Performance Hyperbarics2005-11-17CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865439000263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865439000263008654390002638654390002630865439000263

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
Length104Inch
Outer Diameter34Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Away from sources of heat and chemicals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
410-575-4220sales@newtownehyperbarics.com

Regulatory Flags#

DUNS number
361527229
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852834007003Newtowne Tent ChamberV1.02024-05-28
00852834007065Newtowne HyperbaricsWI2020-03-13
00852834007010Newtowne HyperbaricsC4-27 V2.12019-01-14
00852834007027Newtowne HyperbaricsC4-34 V2.12019-01-14
00852834007034Newtowne HyperbaricsC4-40 V2.12019-01-14
00852834007041Newtowne HyperbaricsS34 V2.02019-01-14
00852834007058Newtowne HyperbaricsS40 V2.02019-01-14
00865439000270Newtowne HyperbaricsS27 V2.02019-01-14
00865439000201Newtowne HyperbaricsClass 4-242016-04-30
00865439000218Newtowne HyperbaricsClass 4-312016-04-30
00865439000225Newtowne HyperbaricsClass 4-382016-04-30
00865439000232Newtowne HyperbaricsSeal 242016-04-30
00865439000249Newtowne HyperbaricsSeal 312016-04-30
00865439000256Newtowne HyperbaricsSeal 382016-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00852678007122BaramedPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852682007996Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2022-08-29
00852682007941Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007958Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007934Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-05-01
00852834007065Newtowne HyperbaricsTYPHOON WATER WARES LTDCBF2020-03-13
00852682007903Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01