Newtowne Hyperbarics

GUDID 00852834007027

Class 4-34" mild hyperbaric chamber

TYPHOON WATER WARES LTD

Hyperbaric chamber, portable
Primary Device ID00852834007027
NIH Device Record Key54074b15-87fb-4554-9b12-7dc37b76ec69
Commercial Distribution StatusIn Commercial Distribution
Brand NameNewtowne Hyperbarics
Version Model NumberC4-34 V2.1
Company DUNS361527229
Company NameTYPHOON WATER WARES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone410-575-4220
Emailsales@newtownehyperbarics.com

Device Dimensions

Outer Diameter34 Inch
Outer Diameter34 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Away from sources of heat and chemicals

Device Identifiers

Device Issuing AgencyDevice ID
GS100852834007027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBFChamber, Hyperbaric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-14
Device Publish Date2019-01-14

On-Brand Devices [Newtowne Hyperbarics]

00865439000270Seal 27" mild hyperbaric chamber
00865439000263Class 7 portable hyperbaric chamber.
00865439000256Seal model, 38" diameter, portable hyperbaric chamber.
00865439000249Seal model, 31" diameter, portable hyperbaric chamber.
00865439000232Seal model, 24" diameter, portable hyperbaric chamber.
00865439000225Class 4 model, 38" diameter, portable hyperbaric chamber.
00865439000218Class 4 model, 31" diameter, portable hyperbaric chamber.
00865439000201Class 4 model, 24" diameter, portable hyperbaric chamber.
00852834007058Seal 40" mild hyperbaric chamber
00852834007041Seal 34" mild hyperbaric chamber
00852834007034Class 4-40" mild hyperbaric chamber
00852834007027Class 4-34" mild hyperbaric chamber
00852834007010Class 4-27" mild hyperbaric chamber
00852834007065Newtowne Hyperbarics Walk In Chamber: 54" Dia x 81" L

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