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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
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. FDA UDI
Model / Reference
Modular Rectangular 6000 + 0 0 8 2 D/L FDA UDI
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. FDA UDI

Identifiers

Catalog Number
Modular Rectangular 6000 + 0 0 8 2 D/L FDA UDI
Primary DI / UDI-DI
08906124940012 FDA UDI
510(k) Number
K002794 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.

Cleared under the same submission

K002794 also covers:

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 233ba888-3e5f-4b70-9c69-2d08dcca3eae 36 fields · synced Jun 8, 2026