TEKNA Manufacturing Pvt. Ltd. Modular Rectangular 6000 0 2 0 S/L

GUDID 08906124943068

Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can accommodate 2 patients in the main lock and a control console for the same. The entire system is ASME PVHO-1 Compliant.

TEKNA MANUFACTURING PRIVATE LIMITED

Hyperbaric chamber, stationary

• Primary Device ID: 08906124943068
• NIH Device Record Key: a8350dd5-8bf9-43fe-8111-b36bcac3531e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEKNA Manufacturing Pvt. Ltd.
• Version Model Number: Modular Rectangular 6000 0 2 0 S/L
• Catalog Number: Modular Rectangular 6000 0 2 0 S/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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08906124943068 [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: 2025-05-12
• Device Publish Date: 2025-05-04

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• 08906124943068: Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can ac
• 08906124943051: Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can ac