DynaRest @Home Innerspring Mattress

GUDID 00840117321243

80" x 36" x 6"

DYNAREX CORPORATION

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Primary Device ID00840117321243
NIH Device Record Key21dd994b-7274-4f15-98c4-4064e64580bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaRest @Home Innerspring Mattress
Version Model Number10436
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117321243 [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 Date2024-05-20
Device Publish Date2024-05-10

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00840117321243 - DynaRest @Home Innerspring Mattress 2024-05-2080" x 36" x 6"
00840117321243 - DynaRest @Home Innerspring Mattress 2024-05-20 80" x 36" x 6"
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