CIV-Clear™ Transducer Cover 610-2367

GUDID 00841436120326

Sterile (10.2x122cm) telescopically-folded cover (no gel)

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00841436120326
• NIH Device Record Key: fafcbeb9-102b-4f9e-b057-58abababd66a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIV-Clear™ Transducer Cover
• Version Model Number: 610-2367
• Catalog Number: 610-2367
• 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: true
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120326 [Package]; Contains: 10841436120323; Package: [24 Units]; In Commercial Distribution
GS1	10841436120323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211270

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

[00841436120326]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-29
• Device Publish Date: 2021-11-20

On-Brand Devices [CIV-Clear™ Transducer Cover]

• 00841436120326: Sterile (10.2x122cm) telescopically-folded cover (no gel)
• 00841436120319: Sterile (14x244cm) telescopically-folded cover
• 00841436120302: Sterile (10.2x122cm) telescopically-folded cover
• 00841436120296: Sterile (8.9x91.5cm) telescopically-folded cover
• 00841436120289: Sterile (14x122cm) telescopically-folded cover
• 00841436120272: Sterile (14x91.5cm) telescopically-folded cover
• 00841436120265: Sterile (14x61cm) flat-folded cover
• 80841436121244: Non-sterile (14x61cm) flat-folded cover