FDA.reportPublic FDA data

Curaplex

Primary DI
00810094575021
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-670255-KIT
Catalog number
301-670255-KIT
Device description
Curaplex THS VibraPEP, Filter, and Neb Kit
Published
2023-02-28
Public version status
New
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)
CAFNebulizer (direct patient interface)
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2
CAFNebulizer (Direct Patient Interface)Anesthesiology2
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094575496PackageGS125In Commercial Distribution
00810094575021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575496008100945754968100945754960810094575496
00810094575021008100945750218100945750210810094575021

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
070556204
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30
00810094573089Curaplex301-44F50-100301-44F50-1002022-04-30
00812277032024Curaplex301-44F50-100301-44F50-1002018-12-15
00812277032055Curaplex301-44F10-120301-44F10-1202018-12-15
00818834028356Curaplex301-12218301-122182022-04-30
00199972000801Curaplex670293-KIT670293-KIT2026-09-30
00199972000825Curaplex670294-KIT2026-09-30
00199972000849Curaplex670295-KIT670295-KIT2026-09-30
00199972000863Curaplex670296-KIT670296-KIT2026-09-30
00199972000887Curaplex670297-KIT670297-KIT2026-09-30
00199972000900Curaplex670298-KIT670298-KIT2026-09-30
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109912Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-09-30
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
04719882305610MaxiPEPENCHANT TEK. CO, LTD.BWF2026-05-28
00848530108809Ventilator accessorySunset Healthcare Solutions, Inc.CAI2026-04-27
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
10889483584705Vital Signs™AIRLIFECAI2025-03-06
10889483591666Vital Signs™AIRLIFECAI2025-02-18