FDA.report

DRIVE

Primary DI
00822383000817
Brand
DRIVE
Company
Drive Devilbiss Healthcare
Model
RTL5021F
Device description
Personal Care Aids to Daily Living Product Description 32" Foldable Reacher,1EA,6/CS
Published
2020-02-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKXAID, TRANSFER

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822384002216PreviousGS10
00822383000817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822384002216008223840022168223840022160822384002216
00822383000817008223830008178223830008170822383000817

GMDN Terms

TermDefinition
Assistive bathing scrub brushA device designed to be used by a person with a disability to assist them in attending to their personal body washing needs. It is a brush with a purpose-made handle or grip that allows the user to wash/scrub all parts of their body whilst bathing; particularly the parts that they cannot reach using their hands.

Sterilization Methods

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

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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

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