SENTINEL® Enteral Feeding Pump S-1000-SI

GUDID 00704411019797

AMSINO INTERNATIONAL, INC.

Enteral feeding pump

• Primary Device ID: 00704411019797
• NIH Device Record Key: 68a30057-7ff6-4650-a070-9c79ff3743e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENTINEL® Enteral Feeding Pump
• Version Model Number: 1
• Catalog Number: S-1000-SI
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00704411019797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011587

FDA Product Code

• LZH: Pump, Infusion, Enteral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-03
• Device Publish Date: 2025-06-25

Devices Manufactured by AMSINO INTERNATIONAL, INC.

• 00704411019797 - SENTINEL® Enteral Feeding Pump: 2025-07-03
• 00704411019797 - SENTINEL® Enteral Feeding Pump: 2025-07-03
• 30704411012669 - AMSure® Closed Suction System for Adults: 2025-07-01 Double Swivel Elbow, 24 hours, Endotracheal, 10Fr 1 Closed Suction Catheter 1 15mm×22mm Flex Adaptor 1 Day Sticker
• 30704411012676 - AMSure® Closed Suction System for Adults: 2025-07-01 Double Swivel Elbow, 24 hours, Endotracheal, 12Fr 1 Closed Suction Catheter 1 15mm×22mm Flex Adaptor 1 Day Sticker
• 30704411012683 - AMSure® Closed Suction System for Adults: 2025-07-01 Double Swivel Elbow, 24 hours, Endotracheal, 14Fr 1 Closed Suction Catheter 1 15mm×22mm Flex Adaptor 1 Day Sticker
• 30704411012690 - AMSure® Closed Suction System for Adults: 2025-07-01 Double Swivel Elbow, 24 hours, Endotracheal, 16Fr, 1 Closed Suction Catheter 1 15mm×22mm Flex Adaptor 1 Day Sticker
• 30704411012706 - AMSure® Closed Suction System for Adults: 2025-07-01 T-Piece, 24 hours, Endotracheal, 10Fr 1 Closed Suction Catheter 1 MDI Adapter 1 22mm Flex Adapter 1 15mm x 22mm Adapter 1 15mm S
• 30704411012713 - AMSure® Closed Suction System for Adults: 2025-07-01 T-Piece, 24 hours, Endotracheal, 12Fr 1 Closed Suction Catheter 1 MDI Adapter 1 22mm Flex Adapter 1 15mm x 22mm Adapter 1 15mm S
• 30704411012720 - AMSure® Closed Suction System for Adults: 2025-07-01 T-Piece, 24 hours, Endotracheal, 14Fr 1 Closed Suction Catheter 1 MDI Adapter 1 22mm Flex Adapter 1 15mm x 22mm Adapter 1 15mm S