FDA.reportPublic FDA data

AirLife™

Primary DI
50190752157550
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
002173R
Catalog number
002173R
Device description
Sidestream™ High-Efficiency Nebulizer
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
50190752157550PackageGS110In Commercial Distribution
10190752157552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215755050190752157550
1019075215755210190752157552

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

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752190535LTV10611106112025-08-26
10190752191518bellavista301.115.010301.115.0102025-07-28
10190752188860bellavista301.115.000301.115.0002025-07-25
10190752191525bellavista301.115.020301.115.0202025-07-25
10190752130364LTV2 Ventilator30509-00130509-0012025-07-16
201907522010613100A HFOV7671637671632025-07-16
10190752185197LTV228774-00128774-0012025-07-16
10190752188754LTV2 Ventilator24425-00124425-0012025-07-16
10190752188761LTV2 Ventilator24426-00124426-0012025-07-16
10190752188808LTV2 Ventilator30512-00130512-0012025-07-16
10190752190368LTV2 Ventilator29242-00129242-0012025-07-16
10190752187818iFlow301.328.020301.328.0202024-11-05
50190752187823iFlow301.328.020301.328.0202024-11-05
50190752200805LTV29660-00129660-0012024-11-05
50190752200829LTV29701-00129701-0012024-11-05
101907522010193100 HFOV11438-PMN11438-PMN2024-11-05
10190752201118LTV10696106962024-11-05
50190752201536LTV11872x1011872x102024-11-05
50190752200751LTV29659-00129659-0012024-08-13
10190752201446LTV15091-10215091-1022024-08-13

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