FDA.reportPublic FDA data

Guardian

Primary DI
00860001236453
Brand
Guardian
Company
TURNCARE INC
Model
GS-2.5-C
Catalog number
GS-2.5-C
Device description
Guardian System, 2.5 Controller
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00860001236453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001236453008600012364538600012364530860001236453

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure inflatorAn electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The inflator, which may be referred to as a pump and may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106254663
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008160300GuardianGS-TBGS-TB2024-11-07
00860008160348GuardianGS-C2025-03-03
00860008160355GuardianGS-SBS-76GS-SBS-762025-03-03
00860008160362GuardianGS-SBS-76-1GS-SBS-76-12025-03-03
00860008160379GuardianGS-EN-BD-76GS-EN-BD-762025-03-03
00860008160386GuardianGS-EN-ST-70GS-EN-ST-702025-03-03
00860008160393GuardianGS-EN-PT-70GS-EN-PT-702025-03-03
00860000205887GuardianGS-2.5-EN-PT-70GS-2.5-EN-PT-702024-11-07
00860000205894GuardianGS-2.5-EN-ST-70GS-2.5-EN-ST-702024-11-07
00860001236491GuardianGS-2.5-EN-BD-76GS-2.5-EN-BD-762024-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28