FDA.reportPublic FDA data

Curaplex

Primary DI
00812277034721
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
BLS-8700KIT
Catalog number
BLS-8700KIT
Device description
Airway CPAP Rescuer Emergency W/ Prem. Lg AD Mask & Neb T
Published
2019-01-31
Public version status
Update
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
QBYPositive airway pressure system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBYPositive Airway Pressure SystemAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094573379PackageGS110In Commercial Distribution
00812277034721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094573379008100945733798100945733790810094573379
00812277034721008122770347218122770347210812277034721

GMDN Terms#

Term, Definition table
TermDefinition
In-line CPAP set, nebulizingA portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a face mask, a nebulizer, and may include additional components (e.g., manometer, flowmeter, tubing, mask strap). This is a reusable device once the consumable products have been replenished.

Sterilization Methods#

Method table
Method

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
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30
00812277035407Curaplex8600-014088600-014082019-08-30
00815277027243Curaplex533-MS-25058EA2016-12-16
00817617022758Curaplex533-MS-25058EA2017-02-06
00817617022918Curaplex533-MS-25058EA533-MS-25058EA2017-09-04
00817617022925Curaplex301-181EA301-181EA2017-12-22
00817617022949Curaplex301-180EA301-180EA2017-09-04
00815277025447Curaplex301-181EA2016-12-14
00815277027250Curaplex533-MS-25060EA2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30810045450026Somnera BackstrapFRESCA MEDICAL, INC.QBY2021-05-07
30810045450040Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
30810045450057Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
30810045450064Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
30810045450088Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
30810045450095Somnera Nasa MaskFRESCA MEDICAL, INC.QBY2021-05-07
30810045450101Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
30810045450132Somnera Airbox Air Filter PackFRESCA MEDICAL, INC.QBY2021-05-07
00810045450025Somnera BackstrapFRESCA MEDICAL, INC.QBY2021-05-07
00810045450049Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
00810045450056Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
00810045450063Somnera PillowFRESCA MEDICAL, INC.QBY2021-05-07
00810045450087Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
00810045450094Somnera Nasa MaskFRESCA MEDICAL, INC.QBY2021-05-07
00810045450100Somnera Nasal MaskFRESCA MEDICAL, INC.QBY2021-05-07
00810045450131Somnera Airbox Air Filter PackFRESCA MEDICAL, INC.QBY2021-05-07
30810045450170Somnera System Nasal MaskFRESCA MEDICAL, INC.QBY2020-12-29
30810045450002Somnera ValveFRESCA MEDICAL, INC.QBY2020-12-28
30810045450019Somnera HeadgearFRESCA MEDICAL, INC.QBY2020-12-28
30810045450033Somnera HoseFRESCA MEDICAL, INC.QBY2020-12-28
30810045450071Somnera Nasal Pillow Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
30810045450118Somnera Nasal Mask Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
30810045450163Somnera System Nasal PillowFRESCA MEDICAL, INC.QBY2020-12-28
00810045450001Somnera ValveFRESCA MEDICAL, INC.QBY2020-12-28
00810045450018Somnera HeadgearFRESCA MEDICAL, INC.QBY2020-12-28
00810045450032Somnera HoseFRESCA MEDICAL, INC.QBY2020-12-28
00810045450070Somnera Nasal Pillow Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
00810045450117Somnera Nasal Mask Fit KitFRESCA MEDICAL, INC.QBY2020-12-28
00810045450162Somnera System Nasal PillowFRESCA MEDICAL, INC.QBY2020-12-28
00812277035377CuraplexBOUND TREE MEDICAL, LLCQBY2019-08-30