Identity
- Trade Name
- Wealy FDA UDI
- Generic Name
- ENFit oral/enteral syringe, reusable FDA UDI
- Device Name
- The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only. FDA UDI
- Model / Reference
- 20ml FDA UDI
- Description
- The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971603585192 FDA UDI
- 510(k) Number
- K203613 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
No
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
Yes
FDA UDI
Category: ENFit oral/enteral syringe, reusable
Wealy by Shantou Wealy Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit oral/enteral syringe, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- 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
- NeoConnect Oral / Enteral Syringe, OTC — NEOMED, INC. · Class II
Cleared under the same submission
K203613 also covers:
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
- Shantou Wealy Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI e5505913-0de1-4d1c-aa66-b909013b4e42 34 fields · synced May 30, 2026