FDA.reportPublic FDA data

Curaplex

Primary DI
00815277027939
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01093
Device description
*Custom* Univ of Minn Bookstore Kit
Published
2016-12-14
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
BTRTube, tracheal (w/wo connector)
DXQblood pressure cuff
KGBMASK, OXYGEN, NON-REBREATHING
MCYWound dressing kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
DXQBlood Pressure CuffCardiovascular2
KGBMask, Oxygen, Non-RebreathingAnesthesiology1
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277027939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277027939008152770279398152770279390815277027939

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
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
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750488KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10080196193066MedlineMEDLINE INDUSTRIES, INC.KGB2023-06-08
08809209590815InBodyInBody Co., Ltd.DXQ2022-07-25
08809209590822InBodyInBody Co., Ltd.DXQ2022-07-25
10080196358649MedlineMEDLINE INDUSTRIES, INC.DXQ2022-03-31
10080196715411MedlineMEDLINE INDUSTRIES, INC.KGB2021-07-13
10190752147799Vital Signs™AIRLIFEBTR2021-06-14
10080196172269MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2021-05-19
10080196358779MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2021-05-19
10080196172245MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DXQ2021-05-18
10190752147751Vital Signs™AIRLIFEBTR2021-04-09
10190752147768Vital Signs™AIRLIFEBTR2021-04-09
10190752147775Vital Signs™AIRLIFEBTR2021-04-09
10190752147782Vital Signs™AIRLIFEBTR2021-04-09
10190752147805Vital Signs™AIRLIFEBTR2021-04-09
10190752147911Vital Signs™AIRLIFEBTR2021-04-09
10190752147928Vital Signs™AIRLIFEBTR2021-04-09
10190752147935Vital Signs™AIRLIFEBTR2021-04-09
10190752147812Vital Signs™AIRLIFEBTR2021-04-02