Patient Safe® 51021

GUDID 00613703510228

Patient Safe® Luer Cap

RETRACTABLE TECHNOLOGIES, INC.

Syringe tip cap Syringe tip cap Syringe tip cap

• Primary Device ID: 00613703510228
• NIH Device Record Key: 9166dde5-5f40-445a-bb42-4e18b41bd006
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Safe®
• Version Model Number: 51021
• Catalog Number: 51021
• Company DUNS: 838024255
• Company Name: RETRACTABLE TECHNOLOGIES, INC.
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-703-1010
• Email: rtiservice@vanishpoint.com
• Phone: 888-703-1010
• Email: rtiservice@vanishpoint.com
• Phone: 888-703-1010
• Email: rtiservice@vanishpoint.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613703510204 [Primary]
GS1	00613703510228 [Package]; Contains: 00613703510204; Package: Case [160 Units]; In Commercial Distribution
GS1	00613703510259 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101708

FDA Product Code

• FMF: Syringe, Piston

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: 2016-09-22

On-Brand Devices [Patient Safe®]

• 00613703560025: 60mL Patient Safe® Syringe
• 00613703530028: 30mL Patient Safe® Syringe
• 00613703520029: 20mL Patient Safe® Syringe
• 00613703510228: Patient Safe® Luer Cap
• 00613703510020: 10mL Patient Safe® Syringe
• 00613703505026: 5mL Patient Safe® Syringe
• 00613703503022: 3mL Patient Safe® Syringe