FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383567242
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
TL500ARE
Device description
BedsLTC Accessories Product Description: Assist Rails, TL500, 1/pr
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
OSIBariatric bed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSIBariatric BedGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383567242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383567242008223835672428223835672420822383567242

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
06979878770015CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770022CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770039CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770053CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770060CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770077CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
B303D040VersaTech 1100 ULBUsine Rotec IncOSI2025-04-11
B303D041VersaTech 1100 ULB+Usine Rotec IncOSI2025-04-11
B303D042VersaTech 1100 ULB+Usine Rotec IncOSI2025-04-11
10197344001750MEDLINEMEDLINE INDUSTRIES, INC.OSI2024-09-27
00817492013186NOA Medical Industries, LLCHoffmann NOA Medical Industries, LLCOSI2024-03-11
00817492013193NOA Medical Industries, LLCHoffmann NOA Medical Industries, LLCOSI2024-03-11
00841447108658Invacare(R) Bariatric Heavy Duty Full Electric Bed with Rails and Mattress KitINVACARE CORPORATIONOSI2023-12-18
00841447199946INVACARE® BARIATRIC TRAPEZEINVACARE CORPORATIONOSI2023-09-21
00817492013117Direct SupplyHoffmann NOA Medical Industries, LLCOSI2023-06-09
04050621100463sentida 6-xlWISSNER-BOSSERHOFF GmbHOSI2023-01-04
00810055882892AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
00810055882908AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
00810055882564AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-05
B303D0300VersaTech 1100 ULBUsine Rotec IncOSI2021-07-05
00815067071555PROBASICSCOMPASS HEALTH BRANDS CORP.OSI2020-09-07
00815067071562PROBASICSCOMPASS HEALTH BRANDS CORP.OSI2020-09-07
00815067071579PROBASICSCOMPASS HEALTH BRANDS CORP.OSI2020-09-07
00822383000442driveDrive Devilbiss HealthcareOSI2020-07-01
00822383551463driveDrive Devilbiss HealthcareOSI2020-07-01
00822383787398WenzeliteDrive Devilbiss HealthcareOSI2020-07-01
00822383935324driveDrive Devilbiss HealthcareOSI2020-07-01
00822383979441driveDrive Devilbiss HealthcareOSI2020-07-01
00822383979533driveDrive Devilbiss HealthcareOSI2020-07-01
00822383979540driveDrive Devilbiss HealthcareOSI2020-07-01