Transducer Cover H2O-005TR

GUDID 00841436120913

Non-sterile (14 x 147cm) telescopically- folded CIV-Flex cover with Envision

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00841436120913
• NIH Device Record Key: 5ec861c8-99a5-4f48-8b74-9c9290e93d1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer Cover
• Version Model Number: H2O-005TR
• Catalog Number: H2O-005TR
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120913 [Package]; Contains: 10841436120910; Package: [200 Units]; In Commercial Distribution
GS1	10841436120910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190802

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [Transducer Cover]

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• 00841436104135: Non-sterile Series 620 (1.8 x 25.5cm) latex cover
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• 00841436103664: Non-sterile (1.5 x 7cm) latex fingercot
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• 00841436103091: Sterile (17.8 x 61cm) flat-folded cover
• 00841436102940: Sterile (10.2 x 147cm) telescopically-folded cover
• 00841436102933: Sterile (8.9 x 91.5cm) telescopically-folded cover
• 00841436102926: Sterile (14 x 147cm) telescopically-folded cover
• 00841436102919: Sterile (14 x 91.5cm) telescopically-folded cover
• 00841436102902: Sterile (14 x 61cm) flat-folded cover
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• 00841436121651: Non-sterile (15.2x244cm) polyethylene telescopically-folded cover
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