FDA.reportPublic FDA data

PTS Connect™ Universal Solution

Primary DI
00381933771015
Brand
PTS Connect™ Universal Solution
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
3771
Catalog number
3771
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.
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381933771015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381933771015003819337710153819337710150381933771015

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information systemA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com
+1(888)877-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381931716018PTS Panels® Triglycerides Test Strips171617162016-07-22
00381934770017CholesterolREF 477047702025-06-16
00381934774015PTS Diagnostics Capillary TubesREF 477447742025-06-16
10381934770014CholesterolREF 477047702025-06-16
10381934774012PTS Diagnostics Capillary TubesREF 477447742025-06-16
00381933080018A1CNow Self Check, 8ct.308030802023-10-25
10381933080015A1CNow Self Check, 8ct.308030802023-10-25
00381934750019CardioChek Plus Home Self-Test Analyzer475047502022-04-11
00381934720012CardioChek Plus Home Self-Test Analyzer472047202021-02-08
00381931708013CardioChek® PA analyzer170817082016-07-15
00381931709010CardioChek® Analyzer170917092016-07-15
00381931757011CardioChek® PA Professional Analyzer, Refurbished175717572016-07-15
00381931782013CardioChek® Analyzer; Refurbished178217822016-07-15
00381932700016CardioChek® Plus Professional Analyzer270027002016-07-15
00381932701013CardioChek® Plus Professional Analyzer270127012016-07-15
00381932702010CardioChek® Plus Professional Analyzer, Refurbished270227022016-07-15
00021292015022TRUE+ A1CNow Self Check307530752023-07-30
00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30
10381932488010Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28