Monoject 8881541034

GUDID 20884521082950

Syringe I.V. Access,Blunt Tip

Cardinal Health, Inc.

Peripheral intravenous catheterization support kit

• Primary Device ID: 20884521082950
• NIH Device Record Key: 4b1bf3bc-291e-478c-80ea-fc853c80e9fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoject
• Version Model Number: 8881541034
• Catalog Number: 8881541034
• 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 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
• 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
• 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
• 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
• 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
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521082953 [Primary]
GS1	20884521082950 [Package]; Contains: 10884521082953; Package: CASE [1000 Units]; In Commercial Distribution
GS1	30884521082957 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960982

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: 2019-12-11
• Device Publish Date: 2016-09-24

On-Brand Devices [Monoject]

• 30884527022742: Insulin Syringe
• 30884527022735: Insulin Syringe
• 20884527022721: Insulin Syringe
• 20884527022714: Insulin Syringe
• 00884521169541: Insulin Syringe
• 00884521169527: Insulin Syringe
• 00884521169503: Insulin Syringe
• 20884527022677: Insulin Syringe
• 30884527022667: Insulin Syringe
• 00884521169442: Insulin Syringe
• 10884527022649: Insulin Syringe
• 20884521151847: Insulin Syringe with Extra Fine Needle
• 20884521151830: Insulin Syringe with Extra Fine Needle
• 20884521151823: Insulin Syringe with Extra Fine Needle
• 30884521010431: Endodontic Needle
• 20884521005690: 0.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill, Blunt Cannula
• 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
• 10884521163683: 0.9% Sodium Chloride,Flush Syringe, 3 mL Fill
• 10884521163676: 0.9% Sodium Chloride,Flush Syringe, 10 mL Fill
• 20884521150093: Blood Collection Tube,Glycerine Coated Lavender Stopper, EDTA (K3) 0.04 mL 15.0% Solution, 4.0 m
• 20884521102757: Needleless Med Prep Cannula
• 20884521102498: Enteral Syringe with Tip Cap
• 20884521082929: Blunt Tip Cannula,Vial Access Pin
• 20884521082493: Vial Access Cannula,Smart Tip
• 10884521082472: Vial Access Combo,Blunt Tip
• 10884521015050: 1 mL Insulin Syringe,Permanent Needle
• 20884521015033: 1 mL Insulin Syringe,Permanent Needle
• 10884521015029: 1 mL Insulin Syringe,Permanent Needle
• 10884521015005: 3/10 mL Insulin Syringe,Permanent Needle
• 10884521014985: 1/2 mL Insulin Syringe,Permanent Needle
• 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
• 20884521008745: Standard Hypodermic Needle,Aluminum Hub
• 20884521008707: Standard Hypodermic Needle,Aluminum Hub
• 20884521008646: Standard Hypodermic Needle,Aluminum Hub
• 20884521008585: Standard Hypodermic Needle,Aluminum Hub
• 20884521008547: Standard Hypodermic Needle,Aluminum Hub
• 20884521008431: Standard Hypodermic Needle,Aluminum Hub
• 20884521008387: Standard Hypodermic Needle,Aluminum Hub