TEKNA Manufacturing Pvt. Ltd. Hybrid 3200/40 Monoplace Hyperbaric Chamber

GUDID 08906124941477

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.

TEKNA MANUFACTURING PRIVATE LIMITED

Hyperbaric chamber, stationary
Primary Device ID08906124941477
NIH Device Record Key92ded2c2-829f-4343-b87f-26a044b9961c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEKNA Manufacturing Pvt. Ltd.
Version Model NumberHybrid 3200 series Monoplace Hyperbaric Chamber
Catalog NumberHybrid 3200/40 Monoplace Hyperbaric Chamber
Company DUNS876896922
Company NameTEKNA MANUFACTURING PRIVATE LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108906124941477 [Primary]

FDA Product Code

CBFChamber, Hyperbaric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-11
Device Publish Date2024-09-03

On-Brand Devices [TEKNA Manufacturing Pvt. Ltd.]

08906124940005Modular Multiplace hyperbaric chamber consisting of ASME 'U' stamped pressure vessel that can ac
08906124941477Hybrid 3200 Series Monoplace Hyperbaric Chamber consisting of ASME 'U' stamped pressure vessel t

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