FDA.report

ThevoautoActiv FR 297 lbs, Split King 38x79", Jersey

Primary DI
04034089066288
Brand
ThevoautoActiv FR 297 lbs, Split King 38x79", Jersey
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800686110004
Published
2022-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04034089066288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04034089066288040340890662884034089066288

GMDN Terms

TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317356343
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04034089107745Swifty 3 Reha-Buggy (LB)98000680901002026-05-26
04034089098623Thevo Flex FR 140kg, 105x200cm, jersey white98006791500442024-04-11
04034089098340ThevoRelief FR 100 100x190 Inko, grey98006930400142024-03-28
040340890953875 point belt, 25mm (Advantage, Swifty)98000848000002023-12-14
04034089096698ThevoautoActive FR 297 lbs, Split King 38x79", inco lip.98006851100142023-12-13
04034089096735ThevoRelief FR 220 lbs, 38 x 79"" (Split King), Inco grey98006931400242023-12-13
04034089093284Under seat storage basket Swifty98000681310002023-07-03
04034089094021ThevoautoActiv FR 110 lbs, Split King 38x79", inco grey98006811000142023-06-06
04034089089287Pneumatic wheels A-chassis, full set98000664701002022-07-19
04034089088235ThevoRelief FR 110 lbs, Hospital size 36x79", inco grey98006910000142023-04-28
04034089088327ThevoFlex FR 308 lbs, Twin size 39x75", inco grey98006780200142023-04-28
04034089089263Pneumatic tires retrofit kit (Swifty 2)98000667110002023-04-28
04034089089294Pneumatic wheels Advantage chassis, full set98000664711002023-04-28
04034089090238ThevoCalm FR 308 lbs, Twin size 39x75", inco grey98006730400142023-04-28
04034089092362ThevoVital FR 176 lbs, Full size 54x75”, jersey white98006282500442023-04-28
04034089092379ThevoVital FR 308 lbs, Full size 54x75", jersey white98006288300442023-04-28
04034089092386ThevoCalm FR 176 lbs, Full size 54x75", jersey white98006720900442023-04-28
04034089092393ThevoCalm FR 308 lbs, Full size 54x75", jersey white98006740700442023-04-28
04034089092409ThevoRelief FR 110 lbs, Full size 54x75”, jersey white98006920800442023-04-28
04034089092416ThevoRelief FR 220 lbs, Full size 54x75", jersey white98006941300442023-04-28

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