Synchronis

Basic Information

• Brand Name: Synchronis
• Primary DI: 00850015884221
• Version / Model: 2161-50000
• Catalog Number: 2161-50000
• Company Name: Synchronis Medical, LLC
• Labeler DUNS: 080160207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-08
• Public Version: 2
• Public Version Date: 2023-05-17
• Public Version Status: Update
• Public Device Record Key: 27f774a7-f248-4b0c-b6a2-94d3a958d673

Device Description

Chest Tube Valve Nonsterile

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	Bottle, Collection, Vacuum	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62752	Pleural drainage valve	A sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850015884238	GS1	Case	50	In Commercial Distribution
Primary	00850015884221	GS1

Customer Contacts

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