FDA.reportPublic FDA data

Flexichamber

Primary DI
00032359490201
Brand
Flexichamber
Company
CERECOR INC.
Model
Anti-Static Valved Collapsible Holding Chamber
Device description
DEMO UNIT
Published
2019-06-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K140062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140062000FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBERFsc Laboratories, Inc.2014-10-03NVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00032359490201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00032359490201000323594902010323594902010032359490201

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968799028
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00323594901011FlexichamberAnti-Static Valved Collapsible Holding Chamber2018-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00822383579269DriveDrive Devilbiss HealthcareNVP2025-09-02
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