FDA.reportPublic FDA data

HUDSON RCI

Primary DI
24026704596984
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN045539
Catalog number
8884717301
Device description
INCENTIVE DEEP BREATHING EXERCISER
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704596984PackageGS112Not in Commercial Distribution
04026704596980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670459698424026704596984
04026704596980040267045969804026704596980

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(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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Primary DI, Brand, Company table
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20197344010346HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
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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
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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