Newtowne Hyperbarics

GUDID 00865439000270

Seal 27" mild hyperbaric chamber

TYPHOON WATER WARES LTD

Hyperbaric chamber, portable

• Primary Device ID: 00865439000270
• NIH Device Record Key: c9e5d721-e155-4e92-9c2d-af938c325128
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newtowne Hyperbarics
• Version Model Number: S27 V2.0
• Company DUNS: 361527229
• Company Name: TYPHOON WATER WARES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 410-575-4220
• Email: sales@newtownehyperbarics.com

Device Dimensions

• Outer Diameter: 27 Inch
• Outer Diameter: 27 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Away from sources of heat and chemicals

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865439000270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051759

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-14
• Device Publish Date: 2019-01-14

On-Brand Devices [Newtowne Hyperbarics]

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