Identity
- Trade Name
- VYGON FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- BULK CLEAR NS2 SYRINGE 2.5ML FDA UDI
- Model / Reference
- 1011.022 FDA UDI
- Description
- BULK CLEAR NS2 SYRINGE 2.5ML FDA UDI
Identifiers
- Catalog Number
- 1011.022 FDA UDI
- Primary DI / UDI-DI
- 30849884002226 FDA UDI
- 510(k) Number
- K060944 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use 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
Yes
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
No
FDA UDI
Category: ENFit oral/enteral syringe, single-use
Vygon by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ENFit oral/enteral syringe, single-use.
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- EXACTAMED — Baxter Healthcare Corp · Class I
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- Ameritus Oral Syringe — KENTEC MEDICAL, INC. · Class I
- BD UniVia — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K060944 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
- Vygon Corp.
Sources (1)
- FDA UDI 797a58ee-a0ff-45d1-b97c-54283bffe8f8 35 fields · synced May 30, 2026