FDA.reportPublic FDA data

Avantia - M-Safe Adjustable Home Bed Rail

Primary DI
00775757766508
Brand
Avantia - M-Safe Adjustable Home Bed Rail
Company
A.M.G. Médicale Inc
Model
776-650
Device description
M-Safe Adjustable Home Bed Rail by Avantia
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNJBed, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00775757766508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00775757766508007757577665087757577665080775757766508

GMDN Terms#

Term, Definition table
TermDefinition
Bedrail padA device which is formed as a flat or contoured fitted cushion made of soft, non-irritating materials designed to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves. It will be mainly used for patients that have little self-control, infants and very young children. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
207372814
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057565166184PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)016-618016-6182023-06-09
00057565166191PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565166283Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565166290Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565166481ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565166498ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565964568PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09
00775757713175Avantia Ultra-Comfort Commode771-3172020-04-20
00775757713151Avantia Portable Steel Commode771-3152020-04-16
00057565168102FeverScan Fever Indicators by Physio Logic016-800016-8002023-06-13
00057565976042FeverScan Fever Indicators by Physio Logic016-800016-8002023-06-13
00775757154251ProActive Alevia 2 in 1 TENS715-425715-4252023-06-12
00775757079301Avantia BPM-70 Automatic Blood Pressure Monitor107-930107-9302023-06-09
00057565975106PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)016-618016-6182023-06-09
00057565975120PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565972846Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565972853Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565973447ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565973461ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565166252PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060631840760Safespace Hi-Lo CompartmentSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
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50606318404940SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-10
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00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
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