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AMSure® Flat Top Piston Irrigation Syringe
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AS116Ref AS015
Identity
- Trade Name
- AMSure® Piston Irrigation Syringe EUDAMEDAMSure® Flat Top Piston Irrigation Syringe FDA UDIAMSure® Piston Enteral Irrigation Syringe FDA UDI
- Generic Name
- Irrigation syringe FDA UDIENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Irrigation Syringe EUDAMEDAMSure® Flat Top Piston Irrigation Syringe Contents: • 1 Flat Top Piston Irrigation Syringe, 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter Caution: Proceed with irrigation procedure, using approved technique. FDA UDIAMSure® Piston Enteral Irrigation Syringe Contents: • 1 Thumb Control Ring • 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter FDA UDI
- Model / Reference
- AS116 EUDAMEDAS015 EUDAMED1 FDA UDI
- Description
- AMSure® Flat Top Piston Irrigation Syringe Contents: • 1 Flat Top Piston Irrigation Syringe, 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter Caution: Proceed with irrigation procedure, using approved technique. FDA UDIAMSure® Piston Enteral Irrigation Syringe Contents: • 1 Thumb Control Ring • 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter FDA UDI
Identifiers
- Catalog Number
- AS115 FDA UDIAS015 FDA UDI
- Primary DI / UDI-DI
- 10704411008477 EUDAMEDFDA UDI10704411006657 EUDAMED10704411010159 FDA UDI
- Basic UDI-DI
- 0704411209YR EUDAMEDB-10704411008477 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
- Irrigation syringe FDA UDIENFit 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 UDIEUDAMED
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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: Irrigation syringe
AMSure® Flat Top Piston Irrigation Syringe by Amsino International, Inc. — Class I — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Irrigation syringe.
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- Monoject — Cardinalhealth · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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 (4)
- FDA UDI db662985-1549-4b4a-8f4f-08e29a996d7c 34 fields · synced Aug 3, 2026
- FDA UDI 5176f4ac-d687-48db-b2a9-05cfd3327891 34 fields · synced May 30, 2026
- EUDAMED eaeff03c-af4d-4bcf-b47b-68d276fc33d3 61 fields · synced Jul 9, 2026
- EUDAMED f46dcfe1-33fc-4b0a-ae98-018b7c88ae40 61 fields · synced Aug 3, 2026