Astra Tee 610-1338

GUDID 00841436111287

ASTRA TEE Transesophageal Probe Reprocessor

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging transducer washer/disinfector

• 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.

• 20841436113087 - GUS: 2024-09-17 G14TC-3-EU
• 20841436122980 - Biopsy Bracket: 2024-09-17 Reusable non-sterile Verza™ bracket for use with FUJIFILM Healthcare MXL65RV and MXL65 transducers
• 20841436125066 - Biopsy Bracket: 2024-09-17 Reusable non-sterile Verza™ bracket for use with Esaote L 8-24 transducers
• 20841436122140 - Biopsy Bracket: 2024-06-28 Reusable non-sterile Verza™ bracket for use with Hologic® C9-2X transducers
• 20841436123284 - Needle Guide Bracket: 2024-06-28 Reusable non-sterile Infiniti Plus™ bracket for use with Siemens HLX transducers
• 00841436122214 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare E72, E721, EC8, E8C-RS, E8CS, IC5-9-D, IC5-9H, IC9B-RS, MTZ, and MZ t
• 00841436123051 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare IC9 transducers. One-cell MEA: =80% embryo developed to expand cytob
• 00841436123068 - Needle Guide: 2024-06-28 Sterile endocavity needle guide for use with GE Healtcare RIC5-9-D, RIC5-9W-RS. RIC6-12-D and Samsung Medison EV3-10B, V5-9 tra