FDA.reportPublic FDA data

Curaplex

Primary DI
00810094573775
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
670246-KIT
Catalog number
670246-KIT
Device description
Curaplex CPR AED Responder Kit, AED Superstore (AMP1011)
Published
2022-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CBPValve, non-rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094573775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094573775008100945737758100945737750810094573775

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, reusableA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B448FS1040Seal QuikFirstar Healthcare Company Limited (Guangzhou)CBP2025-12-10
16946430423013Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2025-06-14
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEIntersurgical IncorporatedCBP2025-04-15
30889483570566AirLife™Sunmed Group Holdings, LLCCBP2025-03-28
16946430421941MENDYOUMEDICALXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2024-11-26
00850055775022BIG EASY, NON-REBREATHING VALVEINNOVATION INSTITUTE, LLCCBP2024-10-30
0503026704086522MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical IncorporatedCBP2024-09-16
09420012480149Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2024-09-11
04719871890011WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890028WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890042WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890059WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890066ARCFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890073WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890080FukuokaFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890097WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890103WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890110LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890608WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890615MEDSTORMFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890622LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890639WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890646WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890653SoutheasternFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890677FirehouseFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890691FOREMOUNTFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890707WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890714Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890721Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890738WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28