Curity 3339

GUDID 20884527016669

Sodium Chloride Dressing

Cardinal Health, Inc.

Wound irrigation sterile saline

• Primary Device ID: 20884527016669
• NIH Device Record Key: 48fd9eb7-4712-4221-ab8c-6c4d0d85ce91
• Commercial Distribution Discontinuation: 2019-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Curity
• Version Model Number: 3339
• Catalog Number: 3339
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch
• Length: 6.75 Inch
• Width: 6 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884527016662 [Primary]
GS1	20884527016669 [Package]; Contains: 10884527016662; Package: CASE [96 Units]; Discontinued: 2019-11-14; Not in Commercial Distribution
GS1	30884527016666 [Package]; Contains: 10884527016662; Package: PACK_OR_INNER_PACK [24 Units]; Discontinued: 2019-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942459

FDA Product Code

• KMF: Bandage, liquid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-14
• Device Publish Date: 2018-06-27

On-Brand Devices [Curity]

• 00884521060541: All Purpose Sponges,Non-woven, 4 Ply
• 00884521060510: All Purpose Sponges,Non-woven, 4 Ply
• 10884521060388: All Purpose Sponges,Nonwoven, 4 Ply
• 10884521000186: AMD Antimicrobial Packing Strips,0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 20884521006604: AMD Antimicrobial Packing Strips,0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 20884521006598: AMD Antimicrobial Packing Strips,0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 30884527020625: Alcohol Prep,2 Ply, Medium
• 20884521134024: Gauze Sponges,16 Ply
• 20884521099675: Gauze Sponges,12 Ply
• 20884521083940: Gauze Pad
• 20884521068695: Plain Packing Strip
• 20884521068688: Plain Packing Strip
• 20884521068671: Plain Packing Strip
• 20884521068664: Plain Packing Strip
• 20884521060309: All Purpose Sponges,Nonwoven, 4 Ply
• 10884521060289: Gauze Pad
• 10884521060265: Gauze Pads
• 20884521059358: Dressing Sponges,6 Ply
• 20884527016348: Bandage Roll
• 10884527008445: X-Ray Detectable Laparotomy Sponges,Tray Pack
• 10884527001125: 100% Cotton OB Sponges,Moderate
• 10884527001118: 100% Cotton OB Sponges,Moderate
• 10884527001101: 100% Cotton OB Sponges,Moderate
• 10884527001064: Cleaners,Large,Moderate
• 10884521157675: Winged Peri-Pad,Moderate
• 10884521157668: Peri-Pad,Moderate
• 10884521144736: Adhesive Bandage
• 10884521144460: Flexible Adhesive Bandage
• 10884521109469: Hypoallergenic Clear Tape
• 10884521109407: Hypoallergenic Clear Tape
• 10884521104723: Hypoallergenic Clear Tape
• 10884521064874: Multi Trauma Dressing
• 30884521060290: Gauze Pad
• 50192253002063: True content to be populated as part of rebranding
• 20884521068732: Iodoform Packing Strip
• 20884521068725: Iodoform Packing Strip
• 20884521068718: Iodoform Packing Strip
• 20884521068701: Iodoform Packing Strip
• 20884527020581: Eye Pad,Oval
• 20884521109275: Hypoallergenic Clear Tape
• 20884527016669: Sodium Chloride Dressing
• 50885380174900: True content to be populated as part of rebranding
• 50885380174894: True content to be populated as part of rebranding
• 50885380174887: True content to be populated as part of rebranding
• 30885380174692: True content to be populated as part of rebranding
• 30885380174685: True content to be populated as part of rebranding
• 30885380174678: True content to be populated as part of rebranding
• 50885380174665: True content to be populated as part of rebranding
• 30885380174654: True content to be populated as part of rebranding
• 30885380174647: True content to be populated as part of rebranding