Identity
- Trade Name
- Ameritus FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- 5ml enteral/oral syringe FDA UDI
- Model / Reference
- AEG5-KMS FDA UDI
- Description
- 5ml enteral/oral syringe FDA UDI
Identifiers
- Catalog Number
- AEG5-KMS FDA UDI
- Primary DI / UDI-DI
- 10817522011295 FDA UDI
- 510(k) Number
- K110853 FDA UDI
- FDA Product Code
- FPD 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
Yes
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
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
Ethylene Oxide FDA UDI
Category: ENFit oral/enteral syringe, single-use
Ameritus by Kentec Medical, Inc. — 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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Cleared under the same submission
K110853 also covers:
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus — KENTEC MEDICAL, INC.
- Ameritus ENFit — KENTEC MEDICAL, INC.
- Ameritus ENFit — KENTEC MEDICAL, INC.
- Ameritus ENFit — KENTEC MEDICAL, INC.
- Ameritus ENFit — KENTEC MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kentec Medical, Inc.
Sources (1)
- FDA UDI d749398a-7274-47c9-9361-8f6a4c7f1e11 36 fields · synced May 30, 2026