Micro-X K100-0100

GUDID 00858293006113

Micro-X Residual Test Strips

REPROCESSING PRODUCTS CORPORATION

Hydrogen peroxide device disinfectant/sterilant test strip

• Primary Device ID: 00858293006113
• NIH Device Record Key: a6552195-c01d-4ff7-b1df-6bab6c2bd69d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-X
• Version Model Number: K100-0100
• Catalog Number: K100-0100
• Company DUNS: 796083392
• Company Name: REPROCESSING PRODUCTS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858293006113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974064

FDA Product Code

• MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-16
• Device Publish Date: 2017-03-07

On-Brand Devices [Micro-X]

• 10858293006332: Micro-X Dialyzer Reprocessing Concentrate
• 00858293006120: Micro-X Peracetic Acid Test Strips - Potency
• 00858293006113: Micro-X Residual Test Strips
• 00858293006922: Micro-X Disinfectant/Sterilant