Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00812277036176
• Version / Model: 8600-01440
• Catalog Number: 8600-01440
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 2
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: 517530f3-45e6-45d1-93ba-6799f72a4ab9

Device Description

*Custom* Berry Blood Draw Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
GJE	TRAY, BLOOD COLLECTION	Clinical Chemistry	862.1675	2
CBT	Arterial blood sampling kit	Anesthesiology	868.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31286	Breathing circuit condensate trap, reusable	A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812277036176	GS1
Package	00810094571337	GS1	CS	50	In Commercial Distribution