FDA.reportPublic FDA data

HUDSON RCI

Primary DI
24026704615227
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049101
Catalog number
8884719011
Device description
VOLDYNE 2500 VOLUMETRIC EXERCISER
Published
2021-01-14
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
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182847000Hudson RCI Voldyne Volumetric ExerciserTeleflexmedical, Inc.2019-07-01BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704615227PackageGS112In Commercial Distribution
14026704615220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670461522724026704615227
1402670461522014026704615220

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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Primary DI, Brand, Company table
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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
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20197344010353HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
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30889483642324AirLife™SUNMED, LLCBWF2025-07-31
10197344097715HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
20197344097712HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
10889483570692AirLife™AIRLIFEBWF2025-02-20
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10889483570807AirLife™AIRLIFEBWF2025-02-11
10889483570814AirLife™AIRLIFEBWF2025-02-11
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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
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