FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022835
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
NSSSTARTB
Device description
USSS START KIT BASIC
Published
2016-12-14
Public version status
Update
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
DXQblood pressure cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277022835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277022835008152770228358152770228350815277022835

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
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
true
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
00634782902636Adcuff™ AMERICAN DIAGNOSTIC CORPDXQ2026-02-23
M3681097002GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823481A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823572A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682360A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X2GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
00810079260089Teladoc Health, Inc.Teladoc Health, Inc.DXQ2026-02-17
16978034830133tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
16978034830140tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
10840935111702Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111719Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111696Patient HoseSUNTECH MEDICAL, INC.DXQ2025-11-18
20197344165343MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165374MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165398MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165339MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165353MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165360MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165384MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14