FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
50822383172922
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
STDS601
Device description
Transport/WheelchairAccessories Product Description: Brake Extension,6",1/ea
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
INPTIPS AND PADS, CANE, CRUTCH AND WALKER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INPTips And Pads, Cane, Crutch And WalkerPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50822383172922PackageGS150In Commercial Distribution
00822383172927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238317292250822383172922
00822383172927008223831729278223831729270822383172927

GMDN Terms#

Term, Definition table
TermDefinition
Portable rampA portable sloping surface designed to bridge a limited gap between two levels. It is used to move objects or persons from one level to another level. The device would typically be used by a person with a disability in a wheelchair needing to move from one level to another in order to enter or exit a vehicle, e.g., an adapted van or a bus.

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
G308ABW92550A Better Walker A BETTER WALKER, LLCINP2026-02-19
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00810178887385ViveVIVE HEALTH LLCINP2026-02-09
10810178882370ViveVIVE HEALTH LLCINP2025-12-05
10810178882387ViveVIVE HEALTH LLCINP2025-12-05
10810178882394ViveVIVE HEALTH LLCINP2025-12-05
30023601017100CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.INP2025-05-21
10194346415820EquateWAL-MART STORES, INC.INP2025-02-28
10810041981971ViveVIVE HEALTH LLCINP2024-10-24
10810041981988ViveVIVE HEALTH LLCINP2024-10-24
10810041981995ViveVIVE HEALTH LLCINP2024-10-24
10810113574759ViveVIVE HEALTH LLCINP2024-10-24
10810113579853ViveVIVE HEALTH LLCINP2024-10-24
10810113579860ViveVIVE HEALTH LLCINP2024-10-24
10810113579877ViveVIVE HEALTH LLCINP2024-10-24
10818323024576ViveVIVE HEALTH LLCINP2024-10-24
10818323024583ViveVIVE HEALTH LLCINP2024-10-24
10818323024590ViveVIVE HEALTH LLCINP2024-10-24
10818323024606ViveVIVE HEALTH LLCINP2024-10-24
50885380115873CARDINAL HEALTHCardinal Health 200, LLCINP2024-09-26
10810113578733ViveVIVE HEALTH LLCINP2024-09-13
10810113578825ViveVIVE HEALTH LLCINP2024-09-13
20057475248295BIOS LivingThermor LtdINP2023-09-15
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00860004575627Assembly Required Distributors Inc.ASSEMBLY REQUIRED DISTRIBUTORS INCINP2023-07-06
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10057475560321BIOS LivingThermor LtdINP2023-03-31