Monoject 8881513256

GUDID 10884521012721

3 mL Syringe with Standard Hypodermic Needle

Cardinal Health, Inc.

Metered-delivery hypodermic syringe

• Primary Device ID: 10884521012721
• NIH Device Record Key: cd3f0d63-075d-44a8-b8cd-0b8c1152a764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoject
• Version Model Number: 8881513256
• Catalog Number: 8881513256
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521012721 [Package]; Contains: 20884521012728; Package: CASE [1000 Units]; In Commercial Distribution
GS1	20884521012728 [Primary]
GS1	30884521012725 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852544

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: 7
• Public Version Date: 2019-06-17
• Device Publish Date: 2016-09-24

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