FDA.reportPublic FDA data

Curaplex

Primary DI
00818834028615
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-44F10-120
Catalog number
301-44F10-120
Device description
VibraPEP Oscillatory PEP Therapy Device Without Tee
Published
2024-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00818834028646PackageGS110In Commercial Distribution
00818834028677PackageGS112In Commercial Distribution
00818834028615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818834028646008188340286468188340286460818834028646
00818834028677008188340286778188340286770818834028677
00818834028615008188340286158188340286150818834028615

GMDN Terms#

Term, Definition table
TermDefinition
Positive pressure airway secretion-clearing deviceA hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting 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.

Regulatory Flags#

DUNS number
010712461
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818834028417Curaplex301-0903301-09032020-11-30
00818834028837MiiS Horus Endoscope Display System -Video BoxEVS 7002025-08-12
00812574026481Curaplex301-P3002EA2017-02-06
00818834028608Curaplex301-12218301-122182024-03-10
00818834028622Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028639Curaplex301-12218301-122182024-03-10
00818834028646Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028684Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028448Curaplex301-PrO2LT301-PrO2LT2024-01-10
00818834028455Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2024-01-10
00818834028462Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2024-01-10
00818834028479Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2024-01-10
00818834028486Curaplex301-PrO2LTEZ301-PrO2LTEZ2024-01-10
00818834028493Curaplex301-PrO2LT-FM301-PrO2LT-FM2024-01-10
00818834028509Curaplex301-PrO2LT-0301-PrO2LT-02024-01-10
00818834028516Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2024-01-10
00812574026221Curaplex301-005-100102017-02-06
00812574025064Curaplex301-005-100102017-12-22
00818834020466Curaplex301-180U301-180U2019-02-10
00818834020473Curaplex301-181U301-181U2019-02-10

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