Astra Tee

Basic Information

• Brand Name: Astra Tee
• Primary DI: 00841436111287
• Version / Model: A9009-01
• Catalog Number: 610-1338
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-23
• Public Version: 8
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: d39b5617-6464-4648-86db-dc0aa159459a

Device Description

ASTRA TEE Transesophageal Probe Reprocessor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61673	Ultrasound imaging transducer washer-disinfector (chemical)	A dedicated electrically-powered unit intended to be used to wash and disinfect ultrasound imaging transducers with the use of appropriate cleaning methods and chemical disinfection. It is typically a stand-alone unit with a washing/disinfecting chamber designed to accept an ultrasound imaging transducer (probe).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841436111287	GS1
Direct Marking	20841436111281	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150504	000

Device Sizes

Type	Value	Unit	Text
Width	12	Inch
Height	48	Inch