Mobility+ OTC Enteral Feeding Device 440 mm MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-

GUDID 05391537090165

The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver commercially available liquid nutrition formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in the clinical or home care settings.

ROCKFIELD MEDICAL DEVICES LIMITED

Enteral feeding noninvasive-component set

• Primary Device ID: 05391537090165
• NIH Device Record Key: 8e532d26-be87-48c8-8934-a2443767b2db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mobility+ OTC Enteral Feeding Device 440 mm
• Version Model Number: MOB2-0440
• Catalog Number: MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-
• Company DUNS: 985605545
• Company Name: ROCKFIELD MEDICAL DEVICES LIMITED
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter
• Length: 440 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391537090127 [Primary]
GS1	05391537090165 [Package]; Contains: 05391537090127; Package: Case [30 Units]; In Commercial Distribution
GS1	05391537090202 [Package]; Contains: 05391537090127; Package: Pack [3 Units]; In Commercial Distribution
GS1	05391537090240 [Package]; Contains: 05391537090202; Package: Case [9 Units]; In Commercial Distribution
GS1	05391537090288 [Package]; Contains: 05391537090127; Package: Pack [10 Units]; In Commercial Distribution
GS1	05391537090325 [Package]; Contains: 05391537090288; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233034

FDA Product Code

• PIF: Gastrointestinal Tubes With Enteral Specific Connectors

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: 2024-07-11
• Device Publish Date: 2024-07-03

Devices Manufactured by ROCKFIELD MEDICAL DEVICES LIMITED

• 05391537090103 - Mobility+ Enteral Feeding Device Bag Purple: 2024-07-11 Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Ente
• 05391537090110 - Mobility+ Enteral Feeding Device Bag Black: 2024-07-11 Mobility+ Enteral Feeding Device Bag is an accessory to the Mobility+ Enteral Feeding Device. The bag enables the Mobility+ Ente
• 05391537090165 - Mobility+ OTC Enteral Feeding Device 440 mm: 2024-07-11The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver commercially available liquid nutrition formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in the clinical or home care settings.
• 05391537090165 - Mobility+ OTC Enteral Feeding Device 440 mm: 2024-07-11 The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral fee
• 05391537090172 - Mobility+ Enteral Feeding Device 700 mm: 2024-07-11 The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral fee
• 05391537090189 - Mobility+ Enteral Feeding Device 1000 mm: 2024-07-11 The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral fee
• 05391537090196 - Mobility+ Enteral Feeding Device 1900 mm: 2024-07-11 The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral fee
• 05391537090004 - Mobility+ Enteral Feeding Device 440 mm: 2023-02-24 The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral fee
• 05391537090011 - Mobility+ Enteral Feeding Device 700 mm: 2023-02-24 The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral fee