Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00812277034134
• Version / Model: 8600-01339
• Catalog Number: 8600-01339
• 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: a8b5d924-8660-400b-97e0-2eb693a9ba84

Device Description

Curaplex 3 Piece XPS Bedding Kit

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
KME	BEDDING, DISPOSABLE, MEDICAL	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60823	Bedding set	A collection of bedding materials including a bed sheet, pillow cover, and a duvet cover all typically made of a thin non-woven or textile laminate intended to create a physical barrier to soiling and cross-contamination. This set is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812277034134	GS1
Package	00810094572860	GS1	CS	30	In Commercial Distribution