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NeoConnect Oral / Enteral Syringe, OTC
FDA UDIClass II (US FDA UDI)
by Neomed, Inc.
Identity
- Trade Name
- NeoConnect Oral / Enteral Syringe, OTC FDA UDI
- Generic Name
- ENFit oral/enteral syringe, reusable FDA UDI
- Device Name
- 12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC FDA UDI
- Model / Reference
- Neo12 FDA UDI
- Description
- 12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC FDA UDI
Identifiers
- Catalog Number
- Neo12 FDA UDI
- Primary DI / UDI-DI
- 00817584013223 FDA UDI
- FDA Product Code
- PNR FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENFit oral/enteral syringe, reusable
NeoConnect Oral / Enteral Syringe, OTC by Neomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit oral/enteral syringe, reusable.
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- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Vesco Medical 60mL Thumb Control Syringe w/ 500mL Container — VESCO MEDICAL LLC · Class II
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- Piston Irrigation Syringe with Enteral Feeding ENFit Connector Flat Top Syringe — Dynarex Corp. · Class I
- Vesco Medical 60mL ENFit Thumb Control Syringe — VESCO MEDICAL LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neomed, Inc.
Sources (1)
- FDA UDI 3e95af9b-bfcc-40e6-b64a-4ea42aeabbf8 35 fields · synced May 30, 2026