FDA.reportPublic FDA data

Curaplex

Primary DI
00810094577148
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
1460-002QM
Catalog number
1460-002QM
Device description
OB Kit Bag
Published
2024-07-30
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
OKUEmergency obstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKUEmergency Obstetrical KitObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094577148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094577148008100945771488100945771480810094577148

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.

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
00817617020518Curaplex8600-011968600-011962016-12-27
00812277034875Curaplex8600-013848600-013842019-07-01
00817617020488Curaplex8600-011938600-011932016-12-27
00817617020495Curaplex8600-011948600-011942016-12-27
00817617020501Curaplex8600-011958600-011952016-12-27
00812277036466Curaplex8600-014538600-014532020-12-30
00812277035230Curaplex1840-20142-A1840-20142-A2019-07-01
00815277020275Curaplex1840-201422016-12-14
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956512832CARDINAL HEALTHCardinal Health 200, LLCOKU2026-07-27
00810094579258Curaplex®BOUND TREE MEDICAL, LLCOKU2025-07-09
00810094579265Curaplex®BOUND TREE MEDICAL, LLCOKU2025-07-09
00810094577223CuraplexBOUND TREE MEDICAL, LLCOKU2024-09-30
00810094577131CuraplexBOUND TREE MEDICAL, LLCOKU2024-07-30
00810094576325CuraplexBOUND TREE MEDICAL, LLCOKU2023-11-10
10195594387662CARDINAL HEALTHCardinal Health 200, LLCOKU2022-05-09
50195594387660CARDINAL HEALTHCardinal Health 200, LLCOKU2022-05-09
10195594515980CARDINAL HEALTHCardinal Health 200, LLCOKU2022-01-23
50195594515988CARDINAL HEALTHCardinal Health 200, LLCOKU2022-01-23
00810071631474CuraplexBOUND TREE MEDICAL, LLCOKU2021-04-01
00810071631535CURAPLEXBOUND TREE MEDICAL, LLCOKU2021-04-01
00812277036596CuraplexBOUND TREE MEDICAL, LLCOKU2020-11-30
10888439835250CARDINAL HEALTHCardinal Health 200, LLCOKU2020-07-21
50888439835258CARDINAL HEALTHCardinal Health 200, LLCOKU2020-07-21
00812277035940CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277035889CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277035919CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277035988CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277036060CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00647921098107MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-11-07
00647921098206MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-11-07
00647921096004MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096202MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096301MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096400MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096509MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096516MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096523MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096530MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01