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AMSure® Piston Enteral Irrigation Syringe
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AS015P
Identity
- Trade Name
- AMSure® Piston Enteral Irrigation Syringe EUDAMEDFDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Irrigation Syringe EUDAMEDAMSure® Piston Enteral Irrigation Syringe • 1 Thumb Control Ring • 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter FDA UDI
- Model / Reference
- AS015P EUDAMED1 FDA UDI
- Description
- AMSure® Piston Enteral Irrigation Syringe • 1 Thumb Control Ring • 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter FDA UDI
Identifiers
- Catalog Number
- AS015P FDA UDI
- Primary DI / UDI-DI
- 10704411010593 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411010593 EUDAMED
- FDA Product Code
- KYZ FDA UDI
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6960 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
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
AMSure® Piston Enteral Irrigation Syringe by Amsino International, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI 33762a0a-a766-4f45-950d-0d6e372ba0dd 34 fields · synced Jun 18, 2026
- EUDAMED cb21cd03-941f-4841-9da4-b15dd0044c13 61 fields · synced Jun 18, 2026