eTRAX™ Needle System Starter Kit 610-1254

GUDID 20841436118082

Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.8 x 147 cm) CIV-Flex™ covers

CIVCO MEDICAL INSTRUMENTS CO., INC.

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• Primary Device ID: 20841436118082
• NIH Device Record Key: 3999c169-98e7-4a6b-8ef0-987d31a67bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eTRAX™ Needle System Starter Kit
• Version Model Number: 610-1254
• Catalog Number: 610-1254
• 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: false
• Lot Batch: true
• Serial Number: true
• 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
• 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

• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter
• Needle Gauge: 12 Gauge
• Length: 17 Centimeter

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
• 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	00841436102797 [Primary]
GS1	20841436118082 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092619

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [eTRAX™ Needle System Starter Kit]

• 00841436111065: Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5) and (7.6 tapered to
• 00841436111058: Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5) and (7.6 tapered to
• 00841436111041: Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5) and (7.6 tapered to 3.
• 00841436111034: Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.
• 00841436109468: Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5) (7.6 tapered to 3.8
• 00841436109383: Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436103435: Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436103428: Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436103206: Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x
• 00841436102063: Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436101844: Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436101110: Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x
• 00841436101103: Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5), (7.6 tapered to 3.8 x
• 00841436101073: Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436100885: Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8
• 00841436100533: Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.
• 00841436100526: Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x
• 00841436100519: Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.8 tapered to 3.8
• 00841436100342: Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.8 tapered to 3.8
• 20841436118082: Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.