FDA.report

CZ-APM

Primary DI
G530CZAPM360
Brand
CZ-APM
Company
Nu Dimension Tech Ventures LLC
Model
36
Catalog number
CZ-APM-36
Device description
Self Adjusting Air Mattress 36 inch
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KICCushion, Flotation

Product Code Classifications

CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G530CZAPM360PrimaryHIBCC0

GMDN Terms

TermDefinition
Flotation therapy bed, adultA mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment.

Sterilization Methods

Method

Regulatory Flags

DUNS number
131179203
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
G530CZAPM420CZ-APM42CZ-APM-422023-11-06
G530CZAPM480CZ-APM48CZ-APM-492023-11-06
G530CZAPMP360CZ-APM-P36CZ-APM-P-362023-11-06
G530CZAPMP420CZ-APM-P42CZ-APM-P-422023-11-06
G530CZAPMP480CZ-APM-P48CZ-APM-P-482023-11-06
G530PATLAL360PAT-LAL36PAT-LAL-36 2023-11-06
G530PATLAL420PAT-LAL42PAT-LAL-422023-11-06
G530PATLAL480PAT-LAL48PAT-LAL-482023-11-06
G530PATLALAP360PAT-ALA-AP36PAT-LAL-AP-36 2023-11-06
G530PATLALAP420PAT-ALA-AP42PAT-LAL-AP-42 2023-11-06
G530PATLALAP480PAT-ALA-AP48PAT-LAL-AP-48 2023-11-06
G530PATLRT360PAT-LRT36PAT-LRT-362023-11-06
G530PATLRT420PAT-LRT42PAT-LRT-422023-11-06
G530PATLRT480PAT-LRT48PAT-LRT-482023-11-06
G530TITAN10000TITAN1000TITAN10002023-11-06
G530TITAN3600E0TITAN3600ETITAN3600E2023-11-06
G530TITAN42000TITAN4200TITAN42002023-11-06
G530TITAN48000TITAN4800TITAN48002023-11-06
G530TITAN54000TITAN5400TITAN54002023-11-06

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00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
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