Xeridiem Medical Devices

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20258512025851Xeridiem Medical Devices1N2026-01-014700 S Overland Dr Tucson AZ US 85714

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00827002447806Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR4805502292David.Hutchinson@SpectrumPlastics.com
00827002447813Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 14 FR4805502292David.Hutchinson@SpectrumPlastics.com
00827002447837Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 18 FR4805502292David.Hutchinson@SpectrumPlastics.com
00827002447844Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 20 FR4805502292David.Hutchinson@SpectrumPlastics.com
00827002447851Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 22 FR4805502292David.Hutchinson@SpectrumPlastics.com
00827002447868Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 24 FR4805502292David.Hutchinson@SpectrumPlastics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
346211151296125K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT ConnectionPIF2023-10-06
346211946410398K180708Entuit 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 Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFitPIF2018-10-18
346211492178883K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionPIF2017-06-06
346212054014409K142297Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension SetPIF2015-01-08
346211634563147K142084EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXOCL2014-10-28
346211004277249K142075BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBEPIF2015-01-08
346211189848204K130674ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBEKNT2014-01-13
346211253291194K130611ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBEKNT2013-12-19
346211636953665K083684ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XXKNT2009-02-05
346211460513664K082203NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025OCL2008-12-30
346211075743239
346211244975346
346211315641994
346211324794281
346211386949806
346211433361506
346211487283802
346211499792446
346211529152663
346211534654875
346211612875253
346211688585552
346211699147477
346211707888640
346211790642464
346211948001012
346212031626816

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PIF72023-10-06
KNT42014-01-13
OCL22014-10-28

PMN#

GUDID#

80 records. Showing 1-40. Next