FDA.reportPublic FDA data

PAT-LAL

Primary DI
G530PATLAL420
Brand
PAT-LAL
Company
Nu Dimension Tech Ventures LLC
Model
42
Catalog number
PAT-LAL-42
Device description
True Low Airloss Air Mattress 42 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

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G530PATLAL420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G530CZAPM360CZ-APM36CZ-APM-362023-11-06
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
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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Primary DI, Brand, Company table
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