Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00812277035889
• Version / Model: 540-1727EA-A
• Catalog Number: 540-1727EA-A
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-30
• Public Version: 2
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: 67fe3361-6283-438b-bc17-ecef6e303a05

Device Description

Curaplex OB Kit, Gloves, Clamps, Scissor, Sponges, Towels, Apron, Tie Off, OB Pad,Underpad,Towelette

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
OKU	Emergency obstetrical kit	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34988	Birthing/delivery kit	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812277035889	GS1
Package	00810094570439	GS1	CS	35	In Commercial Distribution