Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
Xeridiem Medical Devices, A Spectrum Plastics Group Company
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2025851 | 2025851 | Xeridiem Medical Devices | 1 | N | 2026-01-01 | 4700 S Overland Dr Tucson AZ US 85714 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00827002447806 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR | 4805502292 | David.Hutchinson@SpectrumPlastics.com |
| 00827002447813 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 14 FR | 4805502292 | David.Hutchinson@SpectrumPlastics.com |
| 00827002447837 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 18 FR | 4805502292 | David.Hutchinson@SpectrumPlastics.com |
| 00827002447844 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 20 FR | 4805502292 | David.Hutchinson@SpectrumPlastics.com |
| 00827002447851 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 22 FR | 4805502292 | David.Hutchinson@SpectrumPlastics.com |
| 00827002447868 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 24 FR | 4805502292 | David.Hutchinson@SpectrumPlastics.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34621 | 1151296125 | K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | PIF | 2023-10-06 |
| 34621 | 1946410398 | K180708 | 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 Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit | PIF | 2018-10-18 |
| 34621 | 1492178883 | K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | PIF | 2017-06-06 |
| 34621 | 2054014409 | 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 | 2015-01-08 |
| 34621 | 1634563147 | K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | 2014-10-28 |
| 34621 | 1004277249 | K142075 | BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE | PIF | 2015-01-08 |
| 34621 | 1189848204 | K130674 | ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE | KNT | 2014-01-13 |
| 34621 | 1253291194 | K130611 | ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE | KNT | 2013-12-19 |
| 34621 | 1636953665 | K083684 | ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX | KNT | 2009-02-05 |
| 34621 | 1460513664 | K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 | OCL | 2008-12-30 |
| 34621 | 1075743239 | ||||
| 34621 | 1244975346 | ||||
| 34621 | 1315641994 | ||||
| 34621 | 1324794281 | ||||
| 34621 | 1386949806 | ||||
| 34621 | 1433361506 | ||||
| 34621 | 1487283802 | ||||
| 34621 | 1499792446 | ||||
| 34621 | 1529152663 | ||||
| 34621 | 1534654875 | ||||
| 34621 | 1612875253 | ||||
| 34621 | 1688585552 | ||||
| 34621 | 1699147477 | ||||
| 34621 | 1707888640 | ||||
| 34621 | 1790642464 | ||||
| 34621 | 1948001012 | ||||
| 34621 | 2031626816 |
Xeridiem Medical Devices, A Spectrum Plastics Group Company
Xeridiem Medical Devices, A Spectrum Plastics Group Company
Xeridiem Medical Devices
XERIDIEM MEDICAL DEVICES
XERIDIEM MEDICAL DEVICES
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