RPC 7001-3926

GUDID 20858293006018

Injectable Catheter Cap

REPROCESSING PRODUCTS CORPORATION

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• Primary Device ID: 20858293006018
• NIH Device Record Key: b2216e32-857a-4699-9d23-9a9d6a84e859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RPC
• Version Model Number: 7001-3926
• Catalog Number: 7001-3926
• 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	00858293006014 [Primary]
GS1	10858293006011 [Package]; Contains: 00858293006014; Package: package [100 Units]; In Commercial Distribution
GS1	20858293006018 [Package]; Contains: 00858293006014; Package: package [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K855039

FDA Product Code

• GCE: Adaptor, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-07

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• 30858293006046: Ultra-Low Total Chlorine Test Strips - Fresenius
• 10858293006035: Ultra-Low Total Chlorine Test Strips
• 20858293006018: Injectable Catheter Cap
• 20858293006001: Recirculation Connector