Xeridiem Medical Devices A Spectrum Plastics Group Co

FDA Filings

This page includes the latest FDA filings for Xeridiem Medical Devices A Spectrum Plastics Group Co. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2025851
• FEI Number: 2025851
• Name: Xeridiem Medical Devices
• Owner & Operator: Xeridiem Medical Devices, A Spectrum Plastics Group Company
• Contact Address: 4700 SOUTH OVERLAND DR. --; Tucson AZ 85714 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4700 S Overland Dr ; TUCSON, AZ 85714 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K190414 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Nasal tube	2019-10-11
PMN K190414 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Gastrostomy Tube	2019-10-11
PMN K190414 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Nasal tube	2019-10-11
PMN K190414 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Gastrostomy Tube	2019-10-11
PMN K190414 | BSS Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Nasal tube	2019-10-11
PMN K190414 | BSS Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Gastrostomy Tube	2019-10-11
PMN K180708 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PromaX Low Profile Gastrostomy Feeding Tube Kit with ENFit	2018-11-07
PMN K180708 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PromaX LP Patient Care Kit with ENFit	2018-11-07
PMN K180708 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Patient Care Kit	2018-11-07
PMN K180708 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Patient Care Kit with ENFit Connection	2018-11-07
PMN K180708 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube	2018-11-07
PMN K180708 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection	2018-11-07
PMN K180708 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PromaX Low Profile Gastrostomy Feeding Tube Kit with ENFit	2018-11-07
PMN K180708 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PromaX LP Patient Care Kit with ENFit	2018-11-07
PMN K180708 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Patient Care Kit	2018-11-07
PMN K180708 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Patient Care Kit with ENFit Connection	2018-11-07
PMN K180708 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube	2018-11-07
PMN K180708 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection	2018-11-07
PMN K180708 Xeridiem Medical Devices, A Spectrum Plastics Group Company	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube With ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit With ENFit Connection, PromaX Low P	2018-10-18
PMN K182067 | OTK Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PleuraFlow System with FlowGlide Extra Drainage Length	2018-08-15
PMN K182067 | GBX Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PleuraFlow System with FlowGlide Extra Drainage Length	2018-08-15
PMN K163139 | OTK Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PleuraFlow System With FlowGlide	2017-11-01
PMN K163139 | GBX Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	PleuraFlow System With FlowGlide	2017-11-01
PMN K171347 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection	2017-10-12
PMN K171347 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit connector	2017-10-12
PMN K171347 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection	2017-10-12
PMN K171347 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit connector	2017-10-12
PMN K990389 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Moss Gastrostomy Tube	2015-10-14
PMN K142084 | OCL Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EPi-Sense Guided Coagulation System with VisiTrax	2015-10-14
PMN K142075 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes	2015-10-14
PMN K142297 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EndoVive 3s Medication Extension Sets	2015-01-12
PMN K142297 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EndoVive 3s Low Profile Balloon Kit	2015-01-12
PMN K142297 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EndoVive 3s Continuous Extension Sets	2015-01-12
PMN K142297 | PIF Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EndoVive 3s Bolus Extension Sets	2015-01-12
PMN K133881 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	MACY CATHETER	2014-03-05
PMN K130674 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EntuitTM Thrive LP Patient Care Kit	2014-01-30
PMN K130674 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube	2014-01-30
PMN K130674 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EntuitTM Start Stoma Measuring Device	2014-01-30
PMN K130611 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube	2014-01-30
PMN P010055 | MEQ Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	ProstaLund-CoreTherm Catheter	2013-01-29
PMN K873448 | KOD Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	Smiths-Level 1 Foley Catheter with Temperature Sensor	2013-01-29
PMN K082203 | OCL Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	nContact -Numeris Tethered Coagulation Device with VisiTrax	2013-01-29
PMN K083684 | KNT Xeridiem Medical Devices [Xeridiem Medical Devices, A Spectrum Plastics Group Company]	EndoVive	2010-03-29