TEKNA Manufacturing Pvt. Ltd.

GUDID 08906124940005

Modular Multiplace hyperbaric chamber consisting of ASME 'U' stamped pressure vessel that can accommodate 8 patients in the main lock and 2 patients in the entry lock and a control console for the same. The entire system is ASME PVHO-1 compliant.

TEKNA MANUFACTURING PRIVATE LIMITED

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• Primary Device ID: 08906124940005
• NIH Device Record Key: db12a3b8-619e-4d93-9e9c-909ce7e20a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEKNA Manufacturing Pvt. Ltd.
• Version Model Number: Modular Rectangular 6000 + 0 0 8 2 D/L
• Company DUNS: 876896922
• Company Name: TEKNA MANUFACTURING PRIVATE LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	08906124940005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002794

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: 2023-10-09
• Device Publish Date: 2023-09-29