Identity
- Trade Name
- SENTINEL® Enteral Feeding Pump FDA UDI
- Generic Name
- Enteral feeding pump FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- S-1000-SI FDA UDI
- Primary DI / UDI-DI
- 00704411019797 FDA UDI
- 510(k) Number
- K011587 FDA UDI
- FDA Product Code
- LZH FDA UDI
- GMDN Term
- Enteral feeding pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Enteral feeding pump
SENTINEL® Enteral Feeding Pump by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enteral feeding pump.
- Kangaroo — Cardinalhealth · Class II
- Kangaroo — Cardinal Health 200, LLC · Class II
- Kangaroo — Cardinal Health 200, LLC · Class II
- Infinity Enteral Feeding Pump — ZEVEX INTERNATIONAL, INC. · Class II
- Infinity Orange Enteral Feeding Pump — ZEVEX INTERNATIONAL, INC. · Class II
- Kangaroo — Cardinal Health 200, LLC · Class I
- Kangaroo — Cardinalhealth · Class II
- Kangaroo — Cardinalhealth · Class II
Cleared under the same submission
K011587 also covers:
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
- Amsino International, Inc.
Sources (1)
- FDA UDI 68a30057-7ff6-4650-a070-9c79ff3743e7 34 fields · synced May 30, 2026