FDA.reportPublic FDA data

TEKNA Manufacturing Pvt. Ltd.

Primary DI
08906124941477
Brand
TEKNA Manufacturing Pvt. Ltd.
Company
TEKNA MANUFACTURING PRIVATE LIMITED
Model
Hybrid 3200 series Monoplace Hyperbaric Chamber
Catalog number
Hybrid 3200/40 Monoplace Hyperbaric Chamber
Device description
Hybrid 3200 Series Monoplace Hyperbaric Chamber consisting of ASME 'U' stamped pressure vessel that can accommodate 1 patient in the chamber and a control console for the same. The entire system is ASME PVHO-1 compliant.
Published
2024-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBFChamber, Hyperbaric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906124941477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906124941477089061249414778906124941477

GMDN Terms#

Term, Definition table
TermDefinition
Hyperbaric chamber, stationaryA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (813) 788-3969sjanca@hyperbariccentersofflorida.com

Regulatory Flags#

DUNS number
876896922
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906124945116TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 8 0 2 D/L2026-04-30
08906124945123TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 0 4 S/L2026-04-30
08906124944713TEKNA Manufacturing Pvt. Ltd.Modular Multiplace Hyperbaric ChamberModular Rectangular 6000 0 0 1 S/L2026-02-12
08906124943051TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 0 2 S/LModular Rectangular 6000 0 0 2 S/L2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 0 2 0 S/LModular Rectangular 6000 0 2 0 S/L2025-05-04
08906124940012TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 + 0 0 8 2 D/LModular Rectangular 6000 + 0 0 8 2 D/L2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.Modular Rectangular 6000 + 0 0 8 2 D/L2023-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860006478988HMS-5000-6-MINI-QUADROHyperbaric Modular Systems Inc.CBF2026-05-05
08906124945116TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124945123TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124944713TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-02-12
G625R8003410Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-08-20
00850011262016PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2025-07-14
00860006478919HMS-5000Hyperbaric Modular Systems Inc.CBF2025-06-16
G625R800340Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-06-02
08906124943051TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
G623430US Hyperbaric NetworkUS Hyperbaric Network LLCCBF2025-05-02
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCCBF2024-11-21
00852834007003Newtowne Tent ChamberTYPHOON WATER WARES LTDCBF2024-05-28
B878430F0RevitalairOXAVITA S.R.L.CBF2024-01-19
08906124940012TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2023-09-29
00850011262009PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2023-08-07
00860006478940HMS-2000 Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478964HMS-1000Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478926HMS-4000Hyperbaric Modular Systems Inc.CBF2023-08-01
00860006478902HMS-5000-COMPACT-QUADROHyperbaric Modular Systems Inc.CBF2022-10-31
00852678007078Perry BaromedicalPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852678007122BaramedPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852682007996Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2022-08-29
00852682007941Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007958Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007934Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-05-01
00852834007065Newtowne HyperbaricsTYPHOON WATER WARES LTDCBF2020-03-13
00852682007903Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01
00852682007927Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01