Minncare HD 1% Indicator Test Strips

Basic Information

• Brand Name: Minncare HD 1% Indicator Test Strips
• Primary DI: 30677964066895
• Version / Model: 3029796
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-01-09
• Public Version: 5
• Public Version Date: 2022-04-27
• Public Version Status: Update
• Public Device Record Key: 9c327972-2c9f-4d24-b2dc-7001cf4a92ce

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: No
• 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
NIH	Disinfectant, Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40580	Organic peroxy acid device sterilant, single-use	A substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30677964066895	GS1
Unit of Use	00677964066894	GS1

Premarket Submissions

Submission Number	Supplement Number
K133724	000