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Piston Irrigation Syringe with Enteral Feeding ENFit Connector Flat Top Syringe
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Piston Irrigation Syringe with Enteral Feeding ENFit Connector Flat Top Syringe FDA UDI
- Generic Name
- ENFit oral/enteral syringe, reusable FDA UDI
- Device Name
- 60mL,Multiple-use (Includes) 1.Thumb control flat top syringe with ENFit connector ( ENFit connector fits standard ENFit Connections ) ENFit is a registered trademark of GEDSA used with their permission. 2. Tip protector FDA UDI
- Model / Reference
- 4284 FDA UDI
- Description
- 60mL,Multiple-use (Includes) 1.Thumb control flat top syringe with ENFit connector ( ENFit connector fits standard ENFit Connections ) ENFit is a registered trademark of GEDSA used with their permission. 2. Tip protector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784428413 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ENFit oral/enteral syringe, single-useENFit oral/enteral syringe, reusable
Piston Irrigation Syringe with Enteral Feeding ENFit Connector Flat Top Syringe by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as ENFit oral/enteral syringe, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Wealy — Shantou Wealy Medical Instrument Co., Ltd. · Class II
- NeoConnect Oral / Enteral Syringe, OTC — NEOMED, INC. · Class II
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- 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
- NeoConnect Oral / Enteral Syringe, OTC — NEOMED, INC. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 702d108f-0886-4db0-a752-2b68bc69441e 33 fields · synced Jun 1, 2026