Device
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...
Manufacturer
TEKNA MANUFACTURING PRIVATE LIMITED
TEKNA MANUFACTURING PRIVATE LIMITED
Model: Modular Rectangular 6000 0 8 0 2 D/L
DI: 08906124945116
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cb0ccd0c-5ffa-40fe-b429-c96a1cd36d5a
Distribution Status:
In Commercial Distribution
DUNS Number:
876896922
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08906124945116
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12061
Name: Hyperbaric chamber, stationary
Definition:
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FDA Product Codes
CBF
Chamber, Hyperbaric
Premarket Submissions
Submission Number:
K002794
Supplement Number:
000