FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoConnect Oral / Enteral Syringe, OTC
DI: 00817584013216
·
Model: Neo6
·
NEOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NeoConnect Oral / Enteral Syringe, OTC
- Primary DI
- 00817584013216
- Version / Model
- Neo6
- Catalog Number
- Neo6
- Company Name
- NEOMED, INC.
- Labeler DUNS
- 799772079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-06
- Public Version
- 3
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 40a6e4a2-c7a0-4a01-8d0b-a28d8a159c31
Device Description
6mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62001 | ENFit oral/enteral syringe, reusable | A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817584013210 | GS1 | Shipper | 16 | In Commercial Distribution | |
| Package | 10817584013213 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00817584013216 | GS1 |