oneNEST S 303-803508HS4FB-BIL

GUDID 00670482000708

oneNEST S 80''x 35'' is a non-powered foam surface

Umano Medical Inc

Foam bed mattress
Primary Device ID00670482000708
NIH Device Record Key499e0520-8a91-4235-9b67-eedb3919c4b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameoneNEST S
Version Model Number303-803508HS4FB-BIL
Catalog Number303-803508HS4FB-BIL
Company DUNS249675476
Company NameUmano Medical Inc
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
GS100670482000708 [Primary]
GS110670482000705 [Package]
Package: [1 Units]
In Commercial Distribution

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 Date2023-05-09
Device Publish Date2023-05-01

On-Brand Devices [oneNEST S]

00670482000692oneNEST S 84" x 35'' is a non-powered foam surface
00670482000708oneNEST S 80''x 35'' is a non-powered foam surface

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