FDA.reportPublic FDA data

AirLife™

Primary DI
50190752117714
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
RESOC4909A
Catalog number
RESOC4909A
Device description
Volume Incentive Spirometer 4000 mL, in Drawstring Bag
Published
2021-05-07
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
OGLOxygen administration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752117714PackageGS112In Commercial Distribution
10190752117716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075211771450190752117714
1019075211771610190752117716

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser 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 typically 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 or in the home. This is a reusable device.

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10190752129993LTV11581-G11581-G2021-02-22
10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15
10190752114975AirLife™0025010025012020-01-15
10190752114982AirLife™0025020025022020-01-15
10190752114999AirLife™0025300025302020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530104443Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530104450Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530105402Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108915Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108922Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108908Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-20
00848530108595Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108601Repair LabelSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108526Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108533Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108625Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108762Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108649Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108663Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108687Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108646Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108660Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108684Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108571Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108588Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108434Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-18
00848530108311Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-11
00848530108304Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-26
00848530108229REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108243REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108250REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108236REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108240REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108257REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19