Monoject 8881570300

GUDID 10884521005631

0.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill

Cardinal Health, Inc.

Vascular catheter flush syringe

• Primary Device ID: 10884521005631
• NIH Device Record Key: 57a4dcdb-cc87-4c24-b69d-38c0e835b8eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoject
• Version Model Number: 8881570300
• Catalog Number: 8881570300
• 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

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

• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter

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	10884521005631 [Package]; Contains: 30884521005635; Package: PACK_OR_INNER_PACK [20 Units]; In Commercial Distribution
GS1	20884521005638 [Package]; Contains: 30884521005635; Package: CASE [180 Units]; In Commercial Distribution
GS1	30884521005635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032438

FDA Product Code

• NGT: Saline, vascular access flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-15
• Device Publish Date: 2016-09-24

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