EZ-Chek K100-0111

GUDID 00858293006106

Ozone (in Water) Test Strips

REPROCESSING PRODUCTS CORPORATION

Haemodialysis equipment residual chlorine test strip

• Primary Device ID: 00858293006106
• NIH Device Record Key: f8773fd8-847b-4439-92ad-de92644533bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Chek
• Version Model Number: K100-0111
• Catalog Number: K100-0111
• 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	00858293006106 [Primary]
GS1	10858293006103 [Package]; Package: bag [1 Units]; In Commercial Distribution
GS1	20858293006100 [Package]; Contains: 10858293006103; Package: box [1 Units]; In Commercial Distribution
GS1	30858293006107 [Package]; Contains: 20858293006100; Package: carton [22 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132344

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 [EZ-Chek]

• 00858293006397: Blood Leak Test Strip K100-0114 2/pack
• 00858293006380: Residual Chlorine Test Strip K100-0101B 6/pack
• 10858293006325: Residual Chlorine Test Strips
• 00858293006175: Blood Leak Test Strips
• 00858293006168: 4.5 - 10 pH Test Strips
• 00858293006151: 0 -14 pH Test Strips
• 00858293006144: 6.8 - 8.5 pH Test Strips citric acid/bicarbonate dialysate
• 00858293006137: 6.8 - 8.5 pH Test Strips acid/bicarbonate dialysate 100/btl
• 00858293006106: Ozone (in Water) Test Strips
• 00858293006090: Total Chlorine & Chloramine Test Strips