FDA.reportPublic FDA data

AirLife™

Primary DI
10889483570845
Brand
AirLife™
Company
AIRLIFE
Model
001905A
Catalog number
001905A
Device description
Pediatric Volumetric Incentive Spirometer
Published
2025-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791819000AIR INCENTIVE SPIROMETERAirlife, Inc.1979-09-26BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483570849PackageGS112In Commercial Distribution
10190752117167PreviousGS10
10889483570845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948357084930889483570849
1019075211716710190752117167
1088948357084510889483570845

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.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305610MaxiPEPENCHANT TEK. CO, LTD.BWF2026-05-28
00851232007080vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007127vPEPD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007134OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007141OxyPAP PAP DEVICE w/o MANOMETERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007158OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007585PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECED R BURTON HEALTHCARE, LLCBWF2026-04-28
10197344010332HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10197344010349HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10197344010356HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010339HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010346HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010353HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10889483642313AirLife™SUNMED, LLCBWF2025-07-31
10889483642320AirLife™SUNMED, LLCBWF2025-07-31
30889483642317AirLife™SUNMED, LLCBWF2025-07-31
30889483642324AirLife™SUNMED, LLCBWF2025-07-31
10197344097715HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
20197344097712HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
10889483570692AirLife™AIRLIFEBWF2025-02-20
30889483570696AirLife™Sunmed Group Holdings, LLCBWF2025-02-20
10889483570807AirLife™AIRLIFEBWF2025-02-11
10889483570814AirLife™AIRLIFEBWF2025-02-11
10889483570821AirLife™AIRLIFEBWF2025-02-11
10889483570838AirLife™AIRLIFEBWF2025-02-11
30889483570801AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570818AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570825AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570832AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570849AirLife™Sunmed Group Holdings, LLCBWF2025-02-11