Micro-X

GUDID 10858293006332

Micro-X Dialyzer Reprocessing Concentrate

REPROCESSING PRODUCTS CORPORATION

Organic peroxy acid device sterilant, single-use

• Primary Device ID: 10858293006332
• NIH Device Record Key: a27752e8-bdd8-4847-b0e2-273b9a4778ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-X
• Version Model Number: MX-30004
• 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: false
• 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	00858293006335 [Primary]
GS1	10858293006332 [Package]; Contains: 00858293006335; Package: box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962959

FDA Product Code

• MED: Sterilant, Medical Devices

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-19

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