FDA.reportPublic FDA data

Drive

Primary DI
10822383537860
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
MQ-FLETCHERS
Device description
Compressor Nebulizer
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10822383537860PackageGS18In Commercial Distribution
00822383537863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082238353786010822383537860
00822383537863008223835378638223835378630822383537863

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
false
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
false
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
00604351673106MC 300 Reusable NebulizerMonaghan Medical CorporationCAF2026-05-26
44710810080584N/AGALEMED CORPORATIONCAF2026-03-05
44710810082120N/AGALEMED CORPORATIONCAF2026-03-05
44710810082960N/AGALEMED CORPORATIONCAF2026-03-05
44710810084988N/AGALEMED CORPORATIONCAF2026-03-05
44710810085060N/AGALEMED CORPORATIONCAF2026-03-05
44710810085947N/AGALEMED CORPORATIONCAF2026-03-05
44710810086005N/AGALEMED CORPORATIONCAF2026-03-05
44710810088283N/AGALEMED CORPORATIONCAF2026-03-05
44710810088962N/AGALEMED CORPORATIONCAF2026-03-05
44710810089488N/AGALEMED CORPORATIONCAF2026-03-05
44710810110847N/AGALEMED CORPORATIONCAF2026-03-05
44710810112650N/AGALEMED CORPORATIONCAF2026-03-05
20889483230005VixOne™SUNMED, LLCCAF2026-02-11
00199874417059AirpulseAIRPULSE LTDCAF2026-02-03
00810178886371Vive BreatheVIVE HEALTH LLCCAF2026-02-02
00810178884049Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178884681Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178886814Vive BreatheVIVE HEALTH LLCCAF2026-01-30
04719873130153AdheRespHCMED INNOVATIONS CO., LTD.CAF2026-01-29
04719873130207Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130214Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130351Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
00848530107932Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.CAF2026-01-26
04719873131228Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-22
04719873131235Pulmogine®HCMED INNOVATIONS CO., LTD.CAF2026-01-22
46923980103689N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105430N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105461N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105485N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22