Monoject 8881200623

GUDID 10884521152717

Filter Needle,Aluminum Hub

Cardinal Health, Inc.

Medication transfer needle, filtering

• Primary Device ID: 10884521152717
• NIH Device Record Key: e21725d0-dc91-48a0-aad2-ca45c57fa4a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoject
• Version Model Number: 8881200623
• Catalog Number: 8881200623
• 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

• Length: 0.75 Inch
• Length: 0.75 Inch
• Length: 0.75 Inch
• Length: 0.75 Inch

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	10884521152717 [Package]; Contains: 20884521152714; Package: CASE [1000 Units]; In Commercial Distribution
GS1	20884521152714 [Primary]
GS1	30884521152711 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854547

FDA Product Code

• FMI: Needle, hypodermic, single lumen

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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• 00884521169527: Insulin Syringe
• 00884521169503: Insulin Syringe
• 20884527022677: Insulin Syringe
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• 20884521151823: Insulin Syringe with Extra Fine Needle
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• 10884527017966: Filter Needle,Aluminum Hub
• 20884527006752: Blood Collection Tube,Silicone Coated Blue Stopper, Buffered Sodium Citrate 0.5 mL 3.2% Solution
• 10884527006632: Blood Collection Tube,Silicone Coated Lavender Stopper, EDTA (K3) 0.05 mL 15.0% Solution, 5 mL D
• 10884521163706: 0.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill
• 10884521163690: 0.9% Sodium Chloride,Flush Syringe, 5 mL Fill
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• 20884521150093: Blood Collection Tube,Glycerine Coated Lavender Stopper, EDTA (K3) 0.04 mL 15.0% Solution, 4.0 m
• 20884521102757: Needleless Med Prep Cannula
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• 20884521082929: Blunt Tip Cannula,Vial Access Pin
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• 10884521015005: 3/10 mL Insulin Syringe,Permanent Needle
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• 10884521014923: 1/2 mL Insulin Syringe,Permanent Needle
• 10884521014909: 1/2 mL Insulin Syringe,Permanent Needle
• 10884521014480: Safety Syringe Tip Cap
• 20884521013909: 1/2 mL Tuberculin Syringe,Permanent Needle
• 20884521013077: Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
• 20884521012995: Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
• 20884521012971: Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
• 20884521008790: Standard Hypodermic Needle,Aluminum Hub
• 20884521008752: Standard Hypodermic Needle,Aluminum Hub
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• 20884521008585: Standard Hypodermic Needle,Aluminum Hub
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