Data / Medical devices / United States / Xeridiem Medical Devices

Xeridiem Medical Devices: FDA-registered device maker in Tucson, AZ, United States, 5 510(k) clearances

Name: Xeridiem Medical Devices FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Xeridiem Medical Devices is registered with the FDA (registration 2025851) in Tucson, AZ, United States. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 6, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2025851
Address: 4700 S Overland Dr, Tucson, AZ, United States, 85714
Owner or operator: Xeridiem Medical Devices, A Spectrum Plastics Group Company (2025851)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor
First device listed: March 29, 2010
Registered through: 2026
Brand names listed: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit connector; Entuit Gastrostomy BR Balloon Retention Feeding, EndoVive, EndoVive 3s Bolus Extension Sets, EndoVive 3s Continuous Extension Sets, EndoVive 3s Low Profile Balloon Kit, EndoVive 3s Medication Extension Sets, EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube, Foley Catheter with Temperature Sensor and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Irrigation	GBX	1	Contract manufacturer	accessdata.fda.gov
Catheter, Upper Urinary Tract	EYC	2	Contract manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Contract manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Intrauterine Tamponade Balloon	OQY	2	Contract manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Contract manufacturer	accessdata.fda.gov
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	OCM	3	Contract manufacturer	accessdata.fda.gov
System, Applicator, Radionuclide, Manual	IWJ	1	Contract manufacturer	accessdata.fda.gov
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy	MEQ	3	Contract manufacturer	accessdata.fda.gov
Tube, Nasogastric	BSS	2	Contract manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor	accessdata.fda.gov
Wound Drain Catheter System	OTK	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 6, 2023	K232046	Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection	PIF	Substantially Equivalent	Xeridiem Medical Devices, A Spectrum Plastics Group Company	accessdata.fda.gov
June 6, 2017	K171347	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection	PIF	Substantially Equivalent	Xeridiem Medical Devices	accessdata.fda.gov
January 8, 2015	K142297	Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set	PIF	Substantially Equivalent	Xeridiem (Formerly Mri)	accessdata.fda.gov
December 19, 2013	K130611	ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE	KNT	Substantially Equivalent	Xeridiem Medical Devices	accessdata.fda.gov
February 5, 2009	K083684	ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX	KNT	Substantially Equivalent	Manufacturing & Research, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 23, 2015	73024	Class II	Terminated	EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medi	A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.	accessdata.fda.gov

Compare with other makers

Updated October 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.