The following data is part of a premarket notification filed by Xeridiem (formerly Mri) with the FDA for Bi-funnel Gastrostomy Feeding Tube, Tri-funnel Gastrostomy Feeding Tube.
| Device ID | K142075 |
| 510k Number | K142075 |
| Device Name: | BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | XERIDIEM (FORMERLY MRI) 4700 S. OVERLAND DR. Tucson, AZ 85714 |
| Contact | Jesus Valencia |
| Correspondent | Jesus Valencia XERIDIEM (FORMERLY MRI) 4700 S. OVERLAND DR. Tucson, AZ 85714 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-31 |
| Decision Date | 2015-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813939024965 | K142075 | 000 |
| 00813939023916 | K142075 | 000 |
| 00813939023923 | K142075 | 000 |
| 00813939024005 | K142075 | 000 |
| 00813939024012 | K142075 | 000 |
| 00813939024029 | K142075 | 000 |
| 00813939024036 | K142075 | 000 |
| 00813939024043 | K142075 | 000 |
| 00813939024050 | K142075 | 000 |
| 00813939023909 | K142075 | 000 |
| 00813939023619 | K142075 | 000 |
| 20888277411040 | K142075 | 000 |
| 20888277411057 | K142075 | 000 |
| 20888277411064 | K142075 | 000 |
| 20888277411071 | K142075 | 000 |
| 20888277411088 | K142075 | 000 |
| 00813939023862 | K142075 | 000 |
| 00813939023879 | K142075 | 000 |
| 00813939023886 | K142075 | 000 |
| 00813939024067 | K142075 | 000 |
| 00813939024777 | K142075 | 000 |
| 00813939024883 | K142075 | 000 |
| 00813939024890 | K142075 | 000 |
| 00813939024760 | K142075 | 000 |
| 10813939024910 | K142075 | 000 |
| 10813939024927 | K142075 | 000 |
| 10813939024934 | K142075 | 000 |
| 10813939024941 | K142075 | 000 |
| 10813939024958 | K142075 | 000 |
| 00813939024876 | K142075 | 000 |
| 00813939024869 | K142075 | 000 |
| 00813939024784 | K142075 | 000 |
| 00813939024791 | K142075 | 000 |
| 00813939024661 | K142075 | 000 |
| 00813939024814 | K142075 | 000 |
| 00813939024821 | K142075 | 000 |
| 00813939024938 | K142075 | 000 |
| 00813939024845 | K142075 | 000 |
| 00813939024852 | K142075 | 000 |
| 20888277411033 | K142075 | 000 |