RPC K100-0118

GUDID 10858293006035

Ultra-Low Total Chlorine Test Strips

REPROCESSING PRODUCTS CORPORATION

Haemodialysis equipment residual chlorine test strip

• Primary Device ID: 10858293006035
• NIH Device Record Key: e5c00d86-c76b-4da2-a37d-968e9d860484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RPC
• Version Model Number: K100-0118
• Catalog Number: K100-0118
• 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	00858293006038 [Primary]
GS1	10858293006035 [Package]; Contains: 00858293006038; Package: package [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090338

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: 2017-01-19

On-Brand Devices [RPC]

• 00858293006083: K100-0118BX Color Card - Baxter
• 00858293006076: K100-0118F Color Card - Fresenius
• 00858293006069: K100-0118 Color Card
• 10858293006059: Ultra-Low Total Chlorine Test Strips - Baxter
• 30858293006046: Ultra-Low Total Chlorine Test Strips - Fresenius
• 10858293006035: Ultra-Low Total Chlorine Test Strips
• 20858293006018: Injectable Catheter Cap
• 20858293006001: Recirculation Connector