Scanning Kit 610-058, 610-058-5

GUDID 00841436101493

Non-sterile (2.0 x 30cm) NeoGuard™

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

• Primary Device ID: 00841436101493
• NIH Device Record Key: ce4bb33f-c04e-43ef-a2a1-426b326c193b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanning Kit
• Version Model Number: 610-058, 610-058-5
• Catalog Number: 610-058, 610-058-5
• 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
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter
• Width: 2 Centimeter
• Length: 30 Centimeter

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
• 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	00841436101493 [Package]; Contains: 10841436101506; Package: [5 Units]; Discontinued: 2020-12-17; Not in Commercial Distribution
GS1	00841436101509 [Package]; Contains: 10841436101506; Package: [24 Units]; In Commercial Distribution
GS1	10841436101506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013721

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Scanning Kit]

• 00841436108751: Reusable non-sterile standoff with (2.6 x 30cm) latex covers (10) for use with BK Medical Type 8
• 00841436104791: Non-sterile scanning kit with extension tube, (60cc) syringe, 3-way stopcock, latex covers (24)
• 00841436103626: Non-sterile extension tube, (60cc) syringe and 3-way stopcock
• 00841436101493: Non-sterile (2.0 x 30cm) NeoGuard™