Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025851

FEI Number

2025851

Entity Name

Xeridiem Medical Devices

City/State/Country

Tucson, AZ, US

Establishment Address

4700 S Overland Dr, Tucson, AZ 85714, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Xeridiem Medical Devices, A Spectrum Plastics Group Company (Owner Number: 2025851)

Owner / Operator Contact Address

4700 SOUTH OVERLAND DR., --, Tucson, AZ 85714, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EndoVive 3s Low Profile Balloon Kit EndoVive 3s Medication Extension Sets EndoVive 3s Continuous Extension Sets EndoVive 3s Bolus Extension Sets Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit connector; Entuit Gastrostomy BR Balloon Retention Feeding PleuraFlow System With FlowGlide EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube EndoVive Moss Nasal tube Moss Gastrostomy Tube MACY CATHETER PleuraFlow System with FlowGlide Extra Drainage Length PleuraFlow System with FlowGlide Smiths-Level 1 Foley Catheter with Temperature Sensor Moss Gastrostomy Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-12-22
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-01-12
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-10-12
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-10-12
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-11-01
OTK	Wound Drain Catheter System	General, Plastic Surgery	Class 2	878.4780	2017-11-01
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-01-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-03-29
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-10-11
BSS	Tube, Nasogastric	Gastroenterology, Urology	Class 2	876.5980	2019-10-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2019-10-11
OTK	Wound Drain Catheter System	General, Plastic Surgery	Class 2	878.4780	2016-08-16
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2016-08-16
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-03-05
OTK	Wound Drain Catheter System	General, Plastic Surgery	Class 2	878.4780	2018-08-15
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2018-08-15
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-10-14
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2020-10-14
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2021-10-26
OTK	Wound Drain Catheter System	General, Plastic Surgery	Class 2	878.4780	2021-10-26
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-29
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-10-14
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2022-02-09
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2020-10-14

Official Correspondent

Adin Potter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Xeridiem Medical Devices, A Spectrum Plastics Group Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

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1036836	Sterigenics U.S., LLC	Haw River, NC, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025851. Last updated year: 2026. Please use registration number 2025851 when referencing this establishment in official correspondence.