Identity
- Trade Name
- Health Care Logistics, Inc® FDA UDI
- Generic Name
- Non-ISO80369-3-standardized oral syringe FDA UDI
- Device Name
- KwikDose Oral Dispenser 20mL Clear case FDA UDI
- Model / Reference
- 21189C-31 FDA UDI
- Description
- KwikDose Oral Dispenser 20mL Clear case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10827989007618 FDA UDI
- FDA Product Code
- KYX FDA UDI
- GMDN Term
- Non-ISO80369-3-standardized oral syringe 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
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
Yes
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: Non-ISO80369-3-standardized oral syringe
Health Care Logistics, Inc® by Health Care Logistics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-ISO80369-3-standardized oral syringe.
- Oral Tamper Evident Cap — INTERNATIONAL MEDICAL INDUSTRIES INC. · Class I
- Enteral Feeding — Medela LLC · Class II
- BD Oral Syringe — BECTON DICKINSON AND COMPANY · Class I
- KwikDose Oral Dispenser — MedSafety Solutions · Class I
- KwikDose Oral Dispenser — MedSafety Solutions · Class I
- KwikDose Oral Dispenser — MedSafety Solutions · Class I
- KwikDose Oral Dispenser — MedSafety Solutions · Class I
- KwikDose Oral Dispenser — MedSafety Solutions · Class I
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
- Health Care Logistics
Sources (1)
- FDA UDI 26c488b5-410d-4797-9b3a-052bd9473ffa 34 fields · synced Jun 1, 2026