Scanning Kit 610-224

GUDID 00841436103626

Non-sterile extension tube, (60cc) syringe and 3-way stopcock

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

• Primary Device ID: 00841436103626
• NIH Device Record Key: 96f66315-96ee-449e-960a-d81bad7543a1
• Commercial Distribution Discontinuation: 2020-12-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Scanning Kit
• Version Model Number: 610-224
• Catalog Number: 610-224
• 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

Device Dimensions

• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 Inch
• Total Volume: 60 Milliliter
• Length: 6.37 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436103626 [Package]; Contains: 10841436103623; Package: [5 Units]; Discontinued: 2020-12-17; Not in Commercial Distribution
GS1	10841436103623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895614

FDA Product Code

• IYD: Generator, low voltage, therapeutic x-ray

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: 2021-09-03
• 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™