Stratis® C501-20

GUDID 00856457003213

0.5mL Stratis® Reset Station

PHARMAJET, INC.

Injector reset device

• Primary Device ID: 00856457003213
• NIH Device Record Key: 2f422978-5442-47b8-a401-04949a0fc0fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratis®
• Version Model Number: C501-20
• Catalog Number: C501-20
• Company DUNS: 609816892
• Company Name: PHARMAJET, INC.
• 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: false
• 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	00856457003213 [Primary]
GS1	10856457003210 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111517

FDA Product Code

• KZE: Injector, Fluid, Non-Electrically Powered

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: 2016-09-19

On-Brand Devices [Stratis®]

• 00856457003374: Stratis® 13mm Vial Adapter
• 00856457003367: Stratis® Filling Adapter
• 00856457003312: Stratis® 0.5mL Syringe, 10-up
• 00856457003305: Stratis® 0.5mL Syringe, Single-up
• 00856457003213: 0.5mL Stratis® Reset Station
• 00856457003206: 0.5mL Stratis® Injector