Cosyfit Hi-Lo Standard/Wide SR19101

GUDID 05060631842313

SAFESPACES (CORNHOLME) LIMITED

Safe environment patient enclosure
Primary Device ID05060631842313
NIH Device Record Key6d9499ec-916e-49fc-a9a0-b6c5a35e8dcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCosyfit Hi-Lo Standard/Wide
Version Model Number183cm x 122cm - 91cm sides
Catalog NumberSR19101
Company DUNS349371893
Company NameSAFESPACES (CORNHOLME) LIMITED
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 Datetrue
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
GS105060631842313 [Primary]

FDA Product Code

LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-11-24
Device Publish Date2025-11-12

On-Brand Devices [Cosyfit Hi-Lo Standard/Wide]

50606318423200183cm x 122cm - 122cm sides
05060631842566183cm x 122cm - 147cm sides
05060631842504183cm x 122cm - 107cm sides
05060631842313183cm x 122cm - 91cm sides

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