Intuit Roll Transducer Cover 610-1347, 610-1347-5

GUDID 00841436112123

Sterile (14 x 147cm) rolled CIV-Flex™ cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00841436112123
• NIH Device Record Key: aa9c1f67-0c55-4eba-9509-99bb2382cfad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intuit Roll Transducer Cover
• Version Model Number: 610-1347, 610-1347-5
• Catalog Number: 610-1347, 610-1347-5
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., 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: true
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch
• Length: 58 Inch
• Width: 5.5 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436112116 [Package]; Contains: 10841436112113; Package: [24 Units]; In Commercial Distribution
GS1	00841436112123 [Package]; Contains: 10841436112113; Package: [5 Units]; In Commercial Distribution
GS1	10841436112113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970513

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

[00841436112123]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Intuit Roll Transducer Cover]

• 00841436111829: Sterile (14x147cm) rolled CIV-Flex cover with PEELSafe Advantage
• 00841436111249: Sterile (14 x 91.5cm) rolled CIV-Flex™ cover
• 00841436112123: Sterile (14 x 147cm) rolled CIV-Flex™ cover