FDA.reportPublic FDA data

Portex

Primary DI
10351688404008
Brand
Portex
Company
ICU MEDICAL, INC.
Model
002000
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K760762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760762000INCENTIVE SPIROMETERI-Spiron1976-10-08BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688404002PackageGS120In Commercial Distribution
10351688404008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035168840400230351688404002
1035168840400810351688404008

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.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709199061BivonaFT26GN50NGF159N2026-07-22
10887709198095BivonaFT26GN40NGF059N2026-07-21
10887709198521BivonaST26GN65NSC093N2026-07-21
10887709198897BivonaHT26GS50NSC139N2026-07-21
10887709198903BivonaHU26GS50NSC140N2026-07-21
10887709198910BivonaFU26GN45NSF142N2026-07-21
10887709198927BivonaFT26GN60NSF137N2026-07-21
10887709198934BivonaFT26GN70NSC136N2026-07-21
10887709198965BivonaXT26GS60NGF149N2026-07-21
10887709198972BivonaFT26GN40NSF150N2026-07-21
10887709198996BivonaFU26GN40NSF151N2026-07-21
10887709199009BivonaFT26GN45NSF147N2026-07-21
10887709199016BivonaFU26GN50NSF146N2026-07-21
10887709199023BivonaFU26GN45NGF148N2026-07-21
10887709199030BivonaFU26GN30NGE153N2026-07-21
10887709199047BivonaFU26GN35NGE152N2026-07-21
10887709199054BivonaXU26GS45NGF154N2026-07-21
10887709198491BivonaSU26EN50NGF192S2026-07-20
10887709198507BivonaSU26GN40NGF092N2026-07-20
10887709198514BivonaFT26GN60NSC091N2026-07-20

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
10889483570845AirLife™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