Astra Tee 610-1338

GUDID 00841436111287

ASTRA TEE Transesophageal Probe Reprocessor

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging transducer washer/disinfector Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical) Ultrasound imaging transducer washer-disinfector (chemical)

• Primary Device ID: 00841436111287
• NIH Device Record Key: d39b5617-6464-4648-86db-dc0aa159459a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astra Tee
• Version Model Number: A9009-01
• Catalog Number: 610-1338
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Dimensions

• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch
• Width: 12 Inch
• Height: 48 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436111287 [Primary]
GS1	20841436111281 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150504

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-08-23

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

• 20841436122584 - Needle Guide Bracket: 2024-02-16 Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta L18X transducers
• 20841436122614 - Needle Guide Bracket: 2024-02-16 Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta MC10-3 transducers
• 20841436123161 - Biopsy Bracket: 2024-02-16 Reusable non-sterile Verza™ bracket for use with Esaote C 1-8E and CX 1-8A transducers
• 20841436123314 - Biopsy Bracket: 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung CMV1-10 transducers
• 20841436124335 - Biopsy Bracket: 2024-02-16 Reusable non-sterile Verza™ bracket for use with Canon Medical Systems 12L4 transducers
• 20841436124939 - Biopsy Bracket: 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung LA2-16S transducers
• 20841436124960 - Biopsy Bracket: 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung L3-22 transducers
• 00841436120913 - Transducer Cover: 2024-02-16 Non-sterile (14 x 147cm) telescopically- folded CIV-Flex cover with Envision