AeroFly Wheelchair 20:, Gray, SF

GUDID 00822383033211

Drive Devilbiss Healthcare

Push-rim manual wheelchair, non-bariatric
Primary Device ID00822383033211
NIH Device Record Key3da53920-44fd-433e-98f5-0c941a5a4417
Commercial Distribution StatusIn Commercial Distribution
Brand NameAeroFly Wheelchair 20:, Gray, SF
Version Model NumberAF20FDAGY-SF
Company DUNS867673159
Company NameDrive Devilbiss Healthcare
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100822383033211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IORWheelchair, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-19
Device Publish Date2025-11-11

Devices Manufactured by Drive Devilbiss Healthcare

00822383033204 - AeroFly Wheelchair 20:, Black, SF2025-11-19
00822383033211 - AeroFly Wheelchair 20:, Gray, SF2025-11-19
00822383033211 - AeroFly Wheelchair 20:, Gray, SF2025-11-19
00822383033228 - AeroFly Transport Chair, 18", Black2025-11-19
00822383033235 - AeroFly transport Chair, 18", Gray2025-11-19
00822383030333 - Drive2025-09-11
00822383000190 - Drive2025-09-10 35" BRNWOOD BEDEND W/SC05,OSLO FM,EA
00822383000206 - Drive2025-09-10 35" MILL CRK BEDEND W/SC05, OSLO OAK,EA
00822383000213 - Drive2025-09-10 35" MILL CRK BEDEND W/SC05,OSLO CHERRY,EA

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