DRIVEMEDICAL

GUDID 00822383569123

RespiratoryNebs Product Description: PowerNebReusable,AdultMask (102042),6/c

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID00822383569123
NIH Device Record Key95a10399-cc50-4b18-8011-1a93067489e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRIVEMEDICAL
Version Model Number18081-OXYLIFE
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100822383569123 [Primary]
GS150822383569128 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-16
Device Publish Date2016-09-16

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00822383254074Canes & CrutchesAccessories Product Description: QuadCaneTips,SmBse,1/2"Blk,4/BX,24BX/CS
00822383988764PowerPOV 3 wheel Product Description: Spitfire 1320, 12AH, Blue Shroud
50822383985713ElectrotherapyAccessories Product Description: Electrode Pk 1LG/1SM, For RTLAGF-1000
00822383933993PowerMid Wheel Product Description: Titan AXS 22" x 20" Capt. Seat Assemb
00822383933986PowerMid Wheel Product Description: Titan AXS 20" x 20" Capt. Seat Assemb
00822383933979PowerMid Wheel Product Description: Titan AXS 20" x 18" Capt. Seat Assemb
00822383933962PowerMid Wheel Product Description: Titan AXS 18" x 18" Capt. Seat Assemb
00822383933955PowerMid Wheel Product Description: Titan AXS 18" x 16" Capt. Seat Assemb
00822383933948PowerMid Wheel Product Description: Titan AXS 16" x 18" Capt. Seat Assemb
00822383933931PowerMid Wheel Product Description: Titan AXS 16" x 16" Capt. Seat Assemb
00822383933924PowerMid Wheel Product Description: Titan AXS K0823 MWD Base Only
00822383586137Transport/WheelchairWheelchairs K3 Product Description: M3, 20"Lt.WtWheelchair,Det.FullArm,Elv
00822383586120Transport/WheelchairWheelchairs K3 Product Description: M3, 20"Lt.WtWheelchair,Det.DeskArm,Elv
00822383586113Transport/WheelchairWheelchairs K3 Product Description: M3, 18"Lt.WtWheelchair,Det.FullArm,Elv
00822383586106Transport/WheelchairWheelchairs K3 Product Description: M3, 18"Lt.WtWheelchair,Det.DeskArm,Elv
00822383586090Transport/WheelchairWheelchairs K3 Product Description: M3, 16"Lt.WtWheelchair,Det.FullArm,Elv
00822383586083Transport/WheelchairWheelchairs K3 Product Description: M3, 16"Lt.WtWheelchair,Det.DeskArm,Elv
00822383586076Transport/WheelchairWheelchairs K3 Product Description: M3, 20"Lt.WtWheelchair,Det.FullArm,Swg
00822383586069Transport/WheelchairWheelchairs K3 Product Description: M3, 20"Lt.WtWheelchair,Det.DeskArm,Swg
00822383586052Transport/WheelchairWheelchairs K3 Product Description: M3, 18"Lt.WtWheelchair,Det.FullArm,Swg
00822383586045Transport/WheelchairWheelchairs K3 Product Description: M3, 18"Lt.WtWheelchair,Det.DeskArm,Swg
00822383586038Transport/WheelchairWheelchairs K3 Product Description: M3, 16"Lt.WtWheelchair,Det.FullArm,Swg
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00822383584287Transport/WheelchairWheelchairs K1 Product Description: Unassembled Seat and Back Upholstery
00822383584270Transport/WheelchairWheelchairs K1 Product Description: Unassembled Mag Wheels, Rear Axle
00822383584263Transport/WheelchairWheelchairs K1 Product Description: UnassembledFrame,Brake,Cstr,ArmPad,FtRs
50822383582479RollatorsAccessories Product Description: Nitro Cup Holder, 1/ea
50822383576683Pressure PreventionSeat and Back Cushions Product Description: Titanium Gel/Foam W/C cushion 18X
00822383571027Patient RoomHamper stands Product Description: StreamLine Hamper Stand, 1/cs
00822383570471PowerPOV 4 wheel Product Description: ZooMe Flex Folding Travel Scooter, Blue
50822383568459Canes & CrutchesAccessories Product Description: Crutch Pillows,Grey,RTLBX,8BX/CS
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00822383567716Patient RoomIV Poles Product Description: Stand,FloorModel,72", 12/CS
00822383567419BedsSemi Product Description: Compet HiLo Hd/FtBoard wMTR 1 ea
00822383567402BedsSemi Product Description: CompetHd/FtSect,SemiElectwHalfRail1 ea
00822383567396BedsSemi Product Description: CompetHd/FtSect,SemiElectwFullRail1 ea
00822383567389BedsSemi Product Description: CompetHd/FtSect,SemiElect 1 ea
00822383563411BedsLow Product Description: FOOTSPRING&LOW FOOTBOARD F/15005L
00822383563404BedsLow Product Description: HEADSPRING&LOW HEADBOARD F/15005L
50822383563157Canes & CrutchesAccessories Product Description: Utility Replac Tip,7/8",Gry,1PC/BL,10/CV
50822383563140Canes & CrutchesAccessories Product Description: Utility Replac Tip, 1",Gry, 1PC/BL,10/
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50822383563126Canes & CrutchesAccessories Product Description: Crutch Tip, 7/8", BLK, 2 PC/BL, 10/CV
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50822383563089Canes & CrutchesAccessories Product Description: 3/4" GlowInDark CaneTip,Blu,1PC/BL,10/
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