UM40016

GUDID 20884521174839

100% Silicone Urine Meter Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor

Cardinal Health, Inc.

Indwelling urethral catheterization kit

• Primary Device ID: 20884521174839
• NIH Device Record Key: afd95fad-c081-4cfa-b3eb-58941901cb7d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: UM40016
• Catalog Number: UM40016
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• 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

• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter
• Catheter Gauge: 16 French
• Total Volume: 400 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	20884521174839 [Primary]
GS1	30884521174836 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933400

FDA Product Code

• KOD: CATHETER, UROLOGICAL

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

Devices Manufactured by Cardinal Health, Inc.

• 30884521012503 - Monoject: 2024-12-17 Blunt Cannula
• 30884521008094 - Dover: 2024-12-09 Irrigation Tray with Bulb Syringe
• 20884521002156 - Kangaroo: 2024-12-04 Irrigation Syringe with 500 mL Container,60 mL Piston Syringe
• 30884521177264 - Kendall: 2024-11-29 AMD Antimicrobial Foam Border Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
• 20884521177274 - Kendall: 2024-11-29 AMD Antimicrobial Foam Border Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
• 30884521177288 - Kendall: 2024-11-29 AMD Antimicrobial Foam Border Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
• 10884521067585 - SharpSafety: 2024-11-28 Wall Enclosure,For In Room Sharps Container
• 10884521067592 - SharpSafety: 2024-11-28 Glove Box Dispenser,Top Loading