AMSure® Enteral Feeding Pump Spike Set
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AMSure® Enteral Pump Spike Set EUDAMEDAMSure® Enteral Feeding Pump Spike Set FDA UDI
- Generic Name
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
- Device Name
- Enteral Delivery Pump set EUDAMEDAMSure® Enteral Feeding Pump Spike Set Secure Lock Tip, Spike is Compatible with Nestlé's ULTRAPAK® Nutrition Bag, SPIKERIGHT™, For Enteral Feeding Only FDA UDI
- Model / Reference
- ENF1004S EUDAMED1 FDA UDI
- Description
- AMSure® Enteral Feeding Pump Spike Set Secure Lock Tip, Spike is Compatible with Nestlé's ULTRAPAK® Nutrition Bag, SPIKERIGHT™, For Enteral Feeding Only FDA UDI
Identifiers
- Catalog Number
- ESR500 FDA UDI
- Primary DI / UDI-DI
- 10704411015871 EUDAMED10704411005506 FDA UDI
- Basic UDI-DI
- B-10704411015871 EUDAMED
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- A080101 ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE EUDAMED
- GMDN Term
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Enteral feeding kit, adult/paediatric, non-sterile
AMSure® Enteral Feeding Pump Spike Set by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI da13eb4d-306d-4fa1-b3d3-0e332151dc36 34 fields · synced Oct 6, 2026
- EUDAMED 961b03bb-b1b7-4a6c-9d3c-55e60101d55f 61 fields · synced Jul 26, 2026