FDA.reportPublic FDA data

Drive

Primary DI
00822383579269
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
MQ8100
Catalog number
MQ8100
Device description
Airial Chamber with Spotz Mask 1/ea
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVPHolding Chambers, Direct Patient InterfaceAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130598000INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBERInspirx, Inc.2013-06-05NVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10822383579266PackageGS120In Commercial Distribution
00822383579269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082238357926610822383579266
00822383579269008223835792698223835792690822383579269

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
(877) 224-0946customerservice@drivemedical.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10822383579266DriveDrive Devilbiss HealthcareNVP2025-09-02
00604351506121Aerochamber2go Anti-Static Valved Holding ChamberMonaghan Medical CorporationNVP2025-05-30
05023323030054VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-24
05023323029959VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
05023323029973VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
05023323029997VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
05023323030023VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
00383480000594LiteAire BASICTHAYER MEDICAL CORPORATIONNVP2024-09-11
00848530102685Nebulizer KitSUNSET HEALTHCARE SOLUTIONS, INC.NVP2024-08-01
05023323029799InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029812InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029829InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029768InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-24
05023323029782InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-24
05023323029751InspiraChamber®FLEXICARE MEDICAL LIMITEDNVP2024-05-17
05023323029775InspiraChamber® FLEXICARE MEDICAL LIMITEDNVP2024-05-17
00762860001138RESPICHAMBER* VHC with MouthpieceTrudell Medical InternationalNVP2024-03-11
10762860001135RESPICHAMBER* VHC with MouthpieceTrudell Medical InternationalNVP2024-03-11
00604351504127Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2024-03-01
50604351504122Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2024-03-01
00604351501126Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351502123Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351503120Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351500129Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351501121Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351502128Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351503125Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00842135100091Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07
00842135100107Antistatic Compact Space Chamber with Large Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07
10842135100098Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07