Definition: Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using AAMI/CN3(PS):2014 Compliant Connectors.
| Device Type ID | 2111 |
| Device Name | Enteral Syringes With Enteral Specific Connectors |
| Physical State | Plastic Device With Barrel, Movable Plunger, And Connector. |
| Technical Method | The Device Can Be Attached To A Feeding Tube Or Extension Set To Administer Nutrition, Medication, Or Hydration To A Patient Using AAMI/CN3(PS):2014 Compliant Connectors. |
| Target Area | The Gastrointestinal Tract |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2111 |
| Device | Enteral Syringes With Enteral Specific Connectors |
| Product Code | PNR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMSINO INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HOSPIRA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERVENE GROUP LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDELA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDELA HOLDING AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Volume Accuracy Problem | 1 |
| Total Device Problems | 1 |