TEE Kit

Basic Information

• Brand Name: TEE Kit
• Primary DI: 00841436108324
• Version / Model: 811-052
• Catalog Number: 811-052
• 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: 2017-08-22
• Public Version: 4
• Public Version Date: 2021-09-06
• Public Version Status: Update
• Public Device Record Key: 5f00e6d7-0382-45a8-a90a-9a76340fb4aa

Device Description

Rail Adapter, TEE Transducer Holder, CIV-Flex™ Transducer Covers (12)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDJ	CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32288	Surgical camera holder	A device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841436108324	GS1
Direct Marking	20841436118198	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4.5	Inch
Height	3.3	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight