FDA.reportPublic FDA data

PORTEX

Primary DI
35019517123092
Brand
PORTEX
Company
Smiths Medical ASD, Inc.
Model
27-8000
Published
2021-03-12
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
false

Product Codes#

Code, Name table
CodeName
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517123092PackageGS110In Commercial Distribution
15019517123098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951712309235019517123092
1501951712309815019517123098

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical positive pressure airway secretion-clearing deviceA hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. A positive expiratory pressure (PEP) is created when a patient exhales into the device, typically causing a high-density stainless steel ball to rapidly fluctuate up and down to create vibrations in the chest wall which loosens the mucus for expectoration and also assists in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082005361
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
true
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
10887709142029BivonaST24LN70ZSZ142N2025-02-11
10887709141459BivonaFU24LN35NGF086N2025-01-28
10887709139654BivonaZT24KN80NSC005N2025-01-22
10887709136912BivonaZU24JN80NSC259N2025-01-09
10887709141848BivonaST24LN85NSZ127N2025-01-07
10887709142111BivonaZU24LN40NGF133N2025-01-07
10887709142135BivonaFU24LN50NSZ146N2025-01-07
10887709142234BivonaZU24LN30NSE161N2025-01-07
10887709142241BivonaFT24LN50NGC163N2024-12-19
10887709142258BivonaFU24LN40NSA164N2024-12-19
10887709142265BivonaSU24LN60NSB165N2024-12-19
10887709142272BivonaFU24LN35NSF168N2024-12-19
10887709142289BivonaFT24LN55NSF169N2024-12-19
10887709142296BivonaFT24LN40NSE170N2024-12-19
10887709142302BivonaHT24LS55NSA171N2024-12-19
10887709142319BivonaST24LN90NSC124S2024-12-19
10887709142326BivonaFT24LN40NSE166N2024-12-19
10887709142333BivonaSU24LN40NSB167N2024-12-19
10887709142340BivonaHF24LS90NSB174N2024-12-19
10887709142357BivonaFT24LN55NGF172N2024-12-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20197344010353HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
30889483642317AirLife™SUNMED, LLCBWF2025-07-31
30889483642324AirLife™SUNMED, LLCBWF2025-07-31
20197344097712HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
30889483570696AirLife™Sunmed Group Holdings, LLCBWF2025-02-20
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
20885632429771HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
20885632429788HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
20885632429795HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
20885632429801HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
00850021574345Breather Med - cRMT McSc Medical, LLCBWF2024-09-09
01240000013856Breather Med - cRMT Basic UDIMcSc Medical, LLCBWF2024-09-09
50604351505129Aerobika,OPEP Monaghan Medical CorporationBWF2024-05-16
40612479269918McKessonMCKESSON MEDICAL-SURGICAL INC.BWF2024-05-14
40612479269932McKessonMCKESSON MEDICAL-SURGICAL INC.BWF2024-05-14
40612479269956McKessonMCKESSON MEDICAL-SURGICAL INC.BWF2024-05-14
00818834028646CuraplexTRI-ANIM HEALTH SERVICES, INC.BWF2024-03-10
00818834028684CuraplexTRI-ANIM HEALTH SERVICES, INC.BWF2024-03-10
20197344007698HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2023-12-18
10190752117129AirLifeVYAIRE MEDICAL, INC.BWF2023-08-04
10190752117143AirLifeVYAIRE MEDICAL, INC.BWF2023-08-04
20888277409146MedlineMEDLINE INDUSTRIES, INC.BWF2022-06-10
20888277409153MedlineMEDLINE INDUSTRIES, INC.BWF2022-06-10
00810094573119CuraplexBOUND TREE MEDICAL, LLCBWF2022-04-30