FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383104140
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
15050
Device description
BedsRails Product Description: Cross Bars, Universal, 1pr/bx
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00822383104140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383104140008223831041408223831041400822383104140

GMDN Terms#

Term, Definition table
TermDefinition
BedrailA rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00822383012155Silver Sport 16" ReclBackSSP16RBDDAV2026-02-03
00822383012162Silver Sport 16" Full ArmSSP16RBDFAV2026-02-03
00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
00822383030135AeroFly Wheelchair, 18”, Black, SFAF18FDABK-SF2025-11-18
00822383030142AeroFly Wheelchair, 18”, Gray, SFAF18FDAGY-SF2025-11-18
00822383033204AeroFly Wheelchair 20:, Black, SFAF20FDABK-SF2025-11-11
00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
00822383033235AeroFly transport Chair, 18", GrayAFT18GY-SF2025-11-11
00822383030333DriveCFPC17FS2025-09-03
00822383000190Drive35BWBE-FM-SC0535BWBE-FM-SC052025-09-02
00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
00822383000220Drive35MCBE-FM-SC0535MCBE-FM-SC052025-09-02
00822383000237Drive42BWBE-B-SC0542BWBE-B-SC052025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
00766923348109Stay Safe BedPEDICRAFT, INC.FNJ2025-07-21
00766923348123Stay SafePEDICRAFT, INC.FNJ2025-07-21
00845699005437SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005444SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005451SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005482SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
B773KMHBD0KLYOKLYO MEDICAL SYSTEMS INC.FNJ2024-02-23
05050962013520SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962031241SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140530SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140622SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140646SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140691SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962170971SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962171947SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962171985SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962171992SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962172005SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962174184SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962177246SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962177253SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962207929SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962252110SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962253773SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962256378SLEEP SYSTEM NITETIMETHE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02