FDA.reportPublic FDA data

Curaplex

Primary DI
00810094575502
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01511
Catalog number
8600-01511
Device description
*CUSTOM* Curaplex BVM Mask Kit, Size 1 & 2
Published
2023-03-30
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
BTMVentilator, emergency, manual (resuscitator)
CAFNebulizer (direct patient interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094575502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575502008100945755028100945755020810094575502

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
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
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
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752141308AirLife™AIRLIFEBTM2021-05-03
10190752141315AirLife™AIRLIFEBTM2021-05-03
10190752141346AirLife™AIRLIFEBTM2021-05-03
10190752141360AirLife™AIRLIFEBTM2021-05-03
10190752141377AirLife™AIRLIFEBTM2021-05-03
10190752141384AirLife™AIRLIFEBTM2021-05-03
10190752141407AirLife™AIRLIFEBTM2021-05-03
10190752141445AirLife™AIRLIFEBTM2021-05-03
10190752141490AirLife™AIRLIFEBTM2021-05-03
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752141766AirLife™AIRLIFECAF2021-04-02
10190752141940AirLife™AIRLIFECAF2021-04-02
10190752142022AirLife™AIRLIFECAF2021-04-02
10080196418329MedlineMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196715534HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196715558MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196715565MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196731404MedlineMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196731411MedlineMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196731428MedlineMEDLINE INDUSTRIES, INC.CAF2021-03-31
10080196418336MEDLINEMEDLINE INDUSTRIES, INC.CAF2020-12-01
09421032180323Hailie Sensor - for use only with DiskusADHERIUM (NZ) LIMITEDCAF2020-11-19
10190752114265AirLife™VYAIRE MEDICAL, INC.BTM2020-02-04