Sunmed

GUDID 20889483037536

Foley Pediatric Latex 2 Way 3cc 8fr

SUNMED, LLC

Indwelling urethral drainage catheter

• Primary Device ID: 20889483037536
• NIH Device Record Key: c1aca771-97c7-49fc-9792-ef454d2bd807
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunmed
• Version Model Number: 7-6503-08
• Company DUNS: 069009268
• Company Name: SUNMED, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet. Keep out of direct sunlight.
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483037539 [Primary]
GS1	20889483037536 [Package]; Contains: 10889483037539; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082815

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

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: 2018-09-24
• Device Publish Date: 2017-04-11

On-Brand Devices [Sunmed]

• 10889483056523: BATTERY COVER FOR SUNSTIM PLUS
• 10889483056516: BATTERY COVER FOR SUNSTIM
• 10889483055564: SUNSTIM PLUS OVERLAY
• 10889483055557: SUNSTIM OVERLAY
• 20889483048105: E/T TUBE CUFFED 2.5mm 10FR
• 10889483042250: Opthalmoscope Lamp 2.5V
• 10889483042236: Opthalmoscope Lamp 3.5V
• 10889483042212: Opthalmoscope Lamp 3.5V
• 20889483041502: TRACH TUBE CUFFED SZ 9.5mm
• 20889483041496: TRACH TUBE CUFFED SZ 9.0mm
• 20889483041489: TRACH TUBE CUFFED SZ 8.5mm
• 20889483041472: TRACH TUBE CUFFED SZ 8.0mm
• 20889483041465: TRACH TUBE CUFFED SZ 7.5mm
• 20889483041458: TRACH TUBE CUFFED SZ 7.0mm
• 20889483041441: TRACH TUBE CUFFED SZ 6.5mm
• 20889483041434: TRACH TUBE CUFFED SZ 6.0mm
• 20889483041090: REINFORCED E/T TUBE CUFFED 32FR
• 20889483041083: REINFORCED E/T TUBE CUFFED 30FR
• 20889483041076: REINFORCED E/T TUBE CUFFED 28FR
• 20889483041069: REINFORCED E/T TUBE CUFFED 26FR
• 20889483041052: REINFORCED E/T TUBE CUFFED 24FR
• 20889483041045: REINFORCED E/T TUBE CUFFED 22FR
• 20889483041038: REINFORCED E/T TUBE CUFFED 20FR
• 20889483041021: REINFORCED E/T TUBE CUFFED 18FR
• 20889483041014: REINFORCED E/T TUBE CUFFED 16FR
• 20889483041007: REINFORCED E/T TUBED CUFFED 14FR
• 20889483040994: REINFORCED E/T TUBE CUFFED 40FR
• 20889483040765: E/T TUBE CUFFED W/STYLET 8.5mm 34FR
• 20889483040758: E/T TUBE CUFFED W/STYLET 8.0mm 32FR
• 20889483040741: E/T TUBE CUFFED W/STYLET 7.5mm 30FR
• 20889483040734: E/T TUBE CUFFED W/STYLET 7.0mm 28FR
• 20889483040727: E/T TUBE CUFFED W/STYLET 6.5mm 26FR
• 20889483040710: E/T TUBE CUFFED W/STYLET 6.0mm 24FR
• 20889483040703: E/T TUBE CUFFED W/STYLET 5.5mm 22FR
• 20889483040697: E/T TUBE CUFFED W/STYLET 5.00mm 20FR
• 20889483040680: E/T TUBE CUFFED W/STYLET 4.5mm 18FR
• 20889483040673: E/T TUBE CUFFED W/STYLET 4.0mm 16FR
• 20889483040666: E/T TUBE CUFFED W/STYLET 3.5mm 14FR
• 20889483040543: E/T TUBE CUFFED 5.0mm 20FR
• 20889483040536: E/T TUBE CUFFED 4.5mm 18FR
• 20889483040529: E/T TUBE CUFFED 4.0mm 16FR
• 20889483040512: E/T TUBE CUFFED 3.5mm 14FR
• 20889483040505: E/T TUBE CUFFED 3.0mm 12FR
• 20889483040499: E/T TUBE CUFFED 10.0mm 40FR
• 20889483040482: E/T TUBE NO-CUFF 5.5mm 22FR
• 20889483040475: E/T TUBE NO-CUFF 5.0mm 20FR
• 20889483040468: E/T TUBE NO-CUFF 4.5mm 18FR
• 20889483040451: E/T TUBE NO-CUFF 4.0mm 16FR
• 20889483040444: E/T TUBE NO-CUFF 3.5mm 14FR
• 10889483039038: PEEP VALVE 5-20cm 30mm ID X 33mm OD