FDA.reportPublic FDA data

DRIVE

Primary DI
00822383246581
Brand
DRIVE
Company
Drive Devilbiss Healthcare
Model
RTL12004KD
Device description
Bath Safety Benches/stools Product Description Bath Stool, KD, White,RTL,1 EA
Published
2020-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILSADAPTOR, HYGIENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383246581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383246581008223832465818223832465810822383246581

GMDN Terms#

Term, Definition table
TermDefinition
Shower seat, non-poweredA non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.

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
true
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
06975960550671VOCICZhejiang Mateside Medical Devices Technology Co., LtdILS2026-03-17
00810178886012ViveVIVE HEALTH LLCILS2026-02-03
00810178886029ViveVIVE HEALTH LLCILS2026-02-03
00818323028843Vive VIVE HEALTH LLCILS2026-01-30
06979196000016Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000023Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000030Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000047Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000054Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000061Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000078Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000085Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000092Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000108Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000115Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000122Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000139Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000146Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000153Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000160Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000177Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000184Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000191Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000207Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000214Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000221Toilet SeatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000238Toilet SeatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000245Toilet SeatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000252Toilet seatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000269Toilet seatZhongshan Yungu daily products Co., LTD.ILS2025-12-18