Identity
- Trade Name
- Health Care Logistics, Inc® FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Low Dose ENFit Syringe 3mL Amber FDA UDI
- Model / Reference
- 20307 FDA UDI
- Description
- Low Dose ENFit Syringe 3mL Amber FDA UDI
Identifiers
- Catalog Number
- 20307 FDA UDI
- Primary DI / UDI-DI
- 10827989000213 FDA UDI
- 510(k) Number
- K190502 FDA UDI
- FDA Product Code
- PNR 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENFit oral/enteral syringe, single-use
Health Care Logistics, Inc® by Health Care Logistics — Class II — 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
- NeoBottle — NEOMED, INC. · Class I
- EXACTAMED — Baxter Healthcare Corp · Class I
- Ameritus Oral Syringe — KENTEC MEDICAL, INC. · Class I
- VYGON — Vygon Corp. · Class II
- BD UniVia — BECTON DICKINSON AND COMPANY · Class II
- VYGON — Vygon Corp. · Class II
Cleared under the same submission
K190502 also covers:
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Monoject — Cardinal Health 200, LLC
- Health Care Logistics, Inc® — Health Care Logistics
- Health Care Logistics, Inc® — Health Care Logistics
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
- Health Care Logistics
Sources (1)
- FDA UDI 085b7dbf-d699-4b4a-bbdc-9686d272360f 36 fields · synced Jun 8, 2026