Identity
- Trade Name
- UltiCare FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- 1mL oral Syringe FDA UDI
- Model / Reference
- 46001 FDA UDI
- Description
- 1mL oral Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10357515460018 FDA UDI
- FDA Product Code
- KYX FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
UltiCare by Ulti Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit oral/enteral syringe, single-use.
- ENFit Syringe — Avanos Medical, Inc. · Class II
- NeoMed Oral / Enteral Syringe — NEOMED, INC. · Class II
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- NeoBottle — NEOMED, INC. · Class I
- EXACTAMED — Baxter Healthcare Corp · Class I
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- Ameritus Oral Syringe — KENTEC MEDICAL, INC. · Class I
- VYGON — Vygon Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ulti Med, Inc.
Sources (1)
- FDA UDI b629e881-1c3c-4ae9-9f5f-8e05daef114d 33 fields · synced May 30, 2026