Monoject 1181200777T

GUDID 20192253025818

12 mL Syringe Luer-Lock Tip

Cardinal Health, Inc.

General-purpose syringe, single-use

• Primary Device ID: 20192253025818
• NIH Device Record Key: 20f4284f-fe7a-4ad5-af9e-25e16e7fc43e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoject
• Version Model Number: 1181200777T
• Catalog Number: 1181200777T
• Company DUNS: 080935429
• Company Name: Cardinal Health, 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: 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	10192253025811 [Primary]
GS1	20192253025818 [Package]; Contains: 10192253025811; Package: Carton [100 Units]; In Commercial Distribution
GS1	50192253025819 [Package]; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113091

FDA Product Code

• FMF: Syringe, piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

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