Drive

GUDID 10822383963706

PedFishNebwReuse&DispKit (102280),1/ea

Drive Devilbiss Healthcare

Nebulizing system, non-heated

• Primary Device ID: 10822383963706
• NIH Device Record Key: d526f9d7-0e02-4d7a-bfc6-22534e9524da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drive
• Version Model Number: 18091FS-IHO
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383963709 [Primary]
GS1	10822383963706 [Package]; Contains: 00822383963709; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-27

On-Brand Devices [Drive]

• 50689076853632: Pediatric Building Block Compressor Neb
• 50689076853533: Panda Pediatric Neb w/ Disp NK
• 50689076853434: Penguin Compressor Nebulizer
• 50689076799589: Portable Nebulizer
• 50689076551170: Compressor Nebulizer
• 50689076349616: Penguin Compressor Nebulizer, No Bag
• 50689076349210: Compressor Nebulizer
• 50689076349111: Compressor Nebulizer
• 50689076343218: Panda Pediatric Neb w/ Disp NK, no carry bag
• 50689076333110: Panda Pediatric Neb, Pink, w/ Disp NK
• 50689076169115: Airial Express Train
• 50689076168910: Portable Nebulizer
• 50718122220392: Fire Truck Nebulizer w/ Disp NK
• 50794504463823: Portable Nebulizer
• 50779709095062: Hip Kit,1EA,3/CS
• 50779709061210: Low Profile Seat 16Wx18D,1EA
• 10779709060482: Transfer Disc,15",1 EA,2/CS
• 10779709020462: Shoe Horn,Blue,22",1EA,12/CS
• 50779709020446: Personal CareAids to Daily Living Product Description: Plastic Shoehorn,Medium BL,23",1EA,3/CS
• 50779709020415: Plastic ShoeHorn,Blue,16",1EA,3/CS
• 50779709020255: Acrylic Buttonhook 3/4",1EA,3/CS
• 10779709020127: Poly Stocking Aid,1EA,3/CS
• 10779709020103: Molded Sock Aid,1EA,3/CS
• 50822383253492: Grab Bar,Suction,19.5" (500mm),1EA,3/CS
• 50779709012700: Grab Bar,Suction,23.5"(600mm),1EA,3/CS
• 00779709020526: Elastic Shoe Lace,WT,2 PR/PKG,5 PKG/CS
• 00779709020502: Elastic Shoe Lace,BK,2 PR/PKG,5 PKG/CS
• 00822383520780: 14 in invalid ring,1/pr
• 10822383579136: Compressor Nebulizer
• 00822383991788: Spitfire Pro, 4-Wheel 17" Seat, 21AH
• 00822383991771: Spitfire Pro, 3-Wheel 17" Seat, 21AH
• 00822383991764: Spitfire Pro, 4-Wheel 17" Seat, 12AH
• 00822383991757: Spitfire Pro, 3-Wheel 17" Seat, 12AH
• 00822383988658: SemiElec Bed,1/cv
• 00822383988399: Full Elec LowBed 1/cv
• 10822383986620: PedBeagleNeb w/Rx Form(100820),1/ea,6/cv
• 10822383986613: PedFishNeb w/Rx Form(100820),1/ea,6/cv
• 10822383984312: PainAway Pro with Heat 1/ea
• 00822383984032: Spitfire 1320, 12AH, Red Shroud
• 00822383984025: Spitfire 1320, 12AH, Carbon Fiber Shroud
• 10822383982943: PumpOnly W/Connectors, BA9600 Series,1e
• 10822383982936: PumpW/CnctrsOnly,AS-BA9600Series,1ea
• 00822383982823: Prime Care Model P503
• 00822383981635: 35" Self AdjustMatt w/RR and pump-P/L
• 00822383981628: 35" Self Adjust Air/Foam w/pump-P/L
• 00822383979434: Prime Care Model P703, 1ea
• 00822383973425: Pressure PreventionGroup 1 Surfaces Product Description: 5 Zone Mattress with CPU cover-P/L 1501
• 00822383973258: Spitfire EX2, 4-Wheel 17" Seat, 21AH
• 00822383973241: Spitfire EX2, 4-Wheel 17" Seat, 12AH
• 00822383973234: Spitfire EX2, 3-Wheel 17" Seat, 21AH