PerformancePlus™

Basic Information

• Brand Name: PerformancePlus™
• Primary DI: 10813150021149
• Version / Model: A10076
• Catalog Number: A10076
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Labeler DUNS: 002111896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-03-02
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: d9a5338c-6e94-4173-8178-e866ef740cd3

Device Description

Hydrocolloid Prove Cover, Heart Shaped, 50 per package

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
FMT	Warmer, Infant Radiant	General Hospital	880.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33878	Cable/lead/sensor/probe cover, non-sterile	A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10813150021149	GS1
Unit of Use	00813150021142	GS1
Package	20813150021146	GS1	case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K915831	000