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
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23

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