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TEKNA Manufacturing Pvt. Ltd.

FDA UDI

Class II (US FDA UDI)

by Tekna Manufacturing Private Limited

Identity

Trade Name
TEKNA Manufacturing Pvt. Ltd. FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
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. FDA UDI
Model / Reference
Hybrid 3200 series Monoplace Hyperbaric Chamber FDA UDI
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. FDA UDI

Identifiers

Catalog Number
Hybrid 3200/40 Monoplace Hyperbaric Chamber FDA UDI
Primary DI / UDI-DI
08906124941477 FDA UDI
FDA Product Code
CBF FDA UDI
GMDN Term
Hyperbaric chamber, stationary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hyperbaric chamber, stationary

TEKNA Manufacturing Pvt. Ltd. by Tekna Manufacturing Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tekna Manufacturing Private Limited

Sources (1)

  • FDA UDI 92ded2c2-829f-4343-b87f-26a044b9961c 35 fields · synced Jun 1, 2026