FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
00822383233611
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
STDS4Y4706
Device description
Parts Product Description: LegRestAssmComplet w/pad,SSP18RBDDA,1pr
Published
2017-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNNCOMPONENTS, WHEELCHAIR
KNOACCESSORIES, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383233611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383233611008223832336118223832336110822383233611

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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196470723MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
10884389115954MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
40884389115788MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-13
09420082699441Spex SeatingSPEX LIMITEDKNN2026-04-04
09420082699458Spex SeatingSPEX LIMITEDKNN2026-04-04
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
09420051799851Spex SeatingSPEX LIMITEDKNN2025-11-21
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
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09420051794672Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051794689Spex LimitedSPEX LIMITEDKNN2025-11-07
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09420051797529Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051797550Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051797567Spex LimitedSPEX LIMITEDKNN2025-11-07