FDA.reportPublic FDA data

Pure Comfort Breath Exerciser

Primary DI
10860006377837
Brand
Pure Comfort Breath Exerciser
Company
HOME AIDE DIAGNOSTICS, INC.
Model
7830
Device description
Pure Comfort Breath Exerciser
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRHSystem, Breath Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRHSystem, Breath MeasurementClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860006377837PackageGS150In Commercial Distribution
00860006377830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000637783710860006377837
00860006377830008600063778308600063778300860006377830

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8009150116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00860015635518Ultra-Care Disposable Safety Lancets 30GUCSLAN2026-05-05
00850071765069Easy Comfort Safety Lancets 30G 100cntECSLAN2026-05-01
00891237001195Easy Step Blood Glucose Test Strips 50ctT5D2-0011952016-05-03
00891237001423Easy Trak Blood Glucose Test Strips 25ct20002004914232016-05-03
00891237001485Easy Talk Blood Glucose Testing Strips 25ct881814852016-05-03
00891237001645Easy Plus II Blood Glucose Testing Strips 25ct881816452016-05-03
00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC"46542024-10-08
00850027494661"Easy Comfort Syringes 31G 1/2"" 0.3CC"46612024-10-08
00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
00850027494982Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
00850632007225Easy NebMCN-S600MB72252018-01-26
00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
00850027494340True Comfort Knee Compression Wrap43402024-10-08
00850027494357Pure Comfort Leg Massager43572024-10-08
00850027494388Ultra Comfort Body Massager43882024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010197999BT UPGRADE, CUI, INC POWER SUPPLIESQUINTRON INSTRUMENT COMPANY, INC.NRH2025-03-19
00860006377830Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.NRH2024-10-08
00850010197982SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USPQUINTRON INSTRUMENT COMPANY, INC.NRH2024-03-18
05060246860399GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-15
05060246860108GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
05060246860153GastrolyzerBEDFONT SCIENTIFIC LIMITEDNRH2023-06-08
00850010197937LOANER ALVEOVAC EXTRACTORQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197944EXTRACTOR REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-17
00850010197906BT GC LOANER SCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197913BREATHTRACKER SERIES REPAIRQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-16
00850010197234DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197272VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197371STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197210FILTER, FOAM PLUG, 10 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197227Patient Sample Drying TubeQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197869DUST BARRIER, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197265SX2 Plus Maintenance KitQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197876VIAL ADAPTER, PLASTIC, 5 PACKQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197302Tank Support, Safety, Table-Top PlasticQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197357Drying Tube End, Sample Inlet, FemaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197364Drying Tube End, Sample Inlet, MaleQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197883STOPCOCK, ONE-WAY, PLASTICQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197395SivRite-4 Tubing AssemblyQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197418Screwdriver, Valve Removal ToolQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197456Extraction System Output TubingQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197500AlveoVac Exraction System-USA 24VDCQUINTRON INSTRUMENT COMPANY, INC.NRH2023-03-15
00850010197258BreathPrep DesiccantQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197449BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20
00850010197463BreathTrackerQUINTRON INSTRUMENT COMPANY, INC.NRH2022-05-20