ThevoVital FR 176 lbs, Split king 38 x 79", jersey white

GUDID 04034089092614

Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

Orthopaedic bed mattress
Primary Device ID04034089092614
NIH Device Record Key385e03c8-4af9-4b27-840f-c49335541ab4
Commercial Distribution StatusIn Commercial Distribution
Brand NameThevoVital FR 176 lbs, Split king 38 x 79", jersey white
Version Model Number9800628140044
Company DUNS317356343
Company NameThomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104034089092614 [Primary]

FDA Product Code

IKYMattress, Flotation Therapy, Non-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-08
Device Publish Date2023-04-28

Devices Manufactured by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

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04034089094021 - ThevoautoActiv FR 110 lbs, Split King 38x79", inco grey2023-06-14
04034089089287 - Pneumatic wheels A-chassis, full set2023-06-07

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