Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00817617029535
• Version / Model: 670165
• Catalog Number: 670165
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-15
• Public Version: 2
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: 8396f99b-7b48-493c-a3e0-b7640792a347

Device Description

Blood Eldon Card Kit (10 Pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSZ	SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45522	Blood collection paper	A non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817617029535	GS1
Package	00810071639463	GS1	CS	50	In Commercial Distribution