Identity
- Trade Name
- KBMED FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Enteral Feeding Syringe 1ml, pack of 30 FDA UDI
- Model / Reference
- ES1 FDA UDI
- Description
- Enteral Feeding Syringe 1ml, pack of 30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850016172716 FDA UDI
- 510(k) Number
- K182649 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
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
No
FDA UDI
Category: ENFit oral/enteral syringe, single-use
Kbmed by KB Medical (group), Inc. — 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
- 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
Cleared under the same submission
K182649 also covers:
- BodyMed — BOXOUT, LLC
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), 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 |
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Manufacturer
- Manufacturer
- KB Medical (group), Inc.
Sources (1)
- FDA UDI e568321b-4373-42b9-bd6c-3c01fae4c2df 34 fields · synced Jun 8, 2026