envision Ultrasound Pad H2O-001, H2O-001-5

GUDID 00841436114868

Sterile (8.25 x 12.7cm) hydrophilic scanning pad with adhesive

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 00841436114868
• NIH Device Record Key: 6c321a24-3e92-4f8f-8f91-1afe2adad804
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: envision Ultrasound Pad
• Version Model Number: H2O-001, H2O-001-5
• Catalog Number: H2O-001, H2O-001-5
• 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
• 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
• 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: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch
• Length: 3.25 Inch
• Width: 5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• 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
• 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
• 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	00841436114851 [Package]; Contains: 10841436114858; Package: [24 Units]; In Commercial Distribution
GS1	00841436114868 [Package]; Contains: 00841436114851; Package: [5 Units]; In Commercial Distribution
GS1	00841436120203 [Package]; Package: [120 Units]; In Commercial Distribution
GS1	10841436114858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190802

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

[00841436114868]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-27
• Device Publish Date: 2019-06-19

On-Brand Devices [envision Ultrasound Pad]

• 00841436114950: Sterile (8.25 x 12.7cm) hydrophilic ultrasound pad with adhesive
• 00841436114868: Sterile (8.25 x 12.7cm) hydrophilic scanning pad with adhesive