Newtowne Tent Chamber

GUDID 00852834007003

Tent shaped hyperbaric chamber for home with a single front zipper. Patient is seated in a chair while under pressure.

TYPHOON WATER WARES LTD

Hyperbaric chamber, portable

• Primary Device ID: 00852834007003
• NIH Device Record Key: 6b86b9fd-10b3-420d-ba3f-8c643fa4e041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newtowne Tent Chamber
• Version Model Number: V1.0
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852834007003 [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: 2024-06-05
• Device Publish Date: 2024-05-28

Devices Manufactured by TYPHOON WATER WARES LTD

• 00852834007003 - Newtowne Tent Chamber: 2024-06-05Tent shaped hyperbaric chamber for home with a single front zipper. Patient is seated in a chair while under pressure.
• 00852834007003 - Newtowne Tent Chamber: 2024-06-05 Tent shaped hyperbaric chamber for home with a single front zipper. Patient is seated in a chair while under pressure.
• 00852834007065 - Newtowne Hyperbarics: 2020-03-23 Newtowne Hyperbarics Walk In Chamber: 54" Dia x 81" L
• 00852834007010 - Newtowne Hyperbarics: 2019-02-14 Class 4-27" mild hyperbaric chamber
• 00852834007027 - Newtowne Hyperbarics: 2019-02-14 Class 4-34" mild hyperbaric chamber
• 00852834007034 - Newtowne Hyperbarics: 2019-02-14 Class 4-40" mild hyperbaric chamber
• 00852834007041 - Newtowne Hyperbarics: 2019-02-14 Seal 34" mild hyperbaric chamber
• 00852834007058 - Newtowne Hyperbarics: 2019-02-14 Seal 40" mild hyperbaric chamber
• 00865439000270 - Newtowne Hyperbarics: 2019-02-14 Seal 27" mild hyperbaric chamber