PTS Connect™ Universal Solution

Basic Information

• Brand Name: PTS Connect™ Universal Solution
• Primary DI: 00381933771015
• Version / Model: 3771
• Catalog Number: 3771
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 3
• Public Version Date: 2022-04-14
• Public Version Status: Update
• Public Device Record Key: 450e9828-6bd0-4b2b-bda7-2de237c66de5

Device Description

The PTS Connect™ Universal Solution offers the ability to connect wired and wireless PTS Diagnostics analyzers to the PTS Connect Universal Solution. The PTS Connect Universal Solution will collect test results from the connected devices, generate patient results, and allow the user to export data.

Device Characteristics

• Single Use: No
• 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: 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
OUG	Medical device data system	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35477	Clinical laboratory information system	A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00381933771015	GS1

Customer Contacts

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