Medela

GUDID 10859950007020

Polyurethane Enteral Feeding Tube - TwistLok - 16in by 6.5 French

FOOTPRINT MEDICAL, INC.

Nasogastric feeding tube

• Primary Device ID: 10859950007020
• NIH Device Record Key: 72dd53d9-af0b-4183-a682-ecbef0113c6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medela
• Version Model Number: ENPU-16-65
• Company DUNS: 791238046
• Company Name: FOOTPRINT MEDICAL, 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004358316
• Email: xx@xx.xx

Device Dimensions

• Length: 16 Inch
• Length: 16 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859950007023 [Primary]
GS1	10859950007020 [Package]; Contains: 00859950007023; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102548

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-05

On-Brand Devices [Medela]

• 10859950007440: Silicone Enteral Feeding Tube - TwistLok - 90cm by 8 French
• 10859950007433: Silicone Enteral Feeding Tube - TwistLok - 90cm by 6.5 French
• 10859950007426: Silicone Enteral Feeding Tube - TwistLok - 90cm by 5 French
• 10859950007419: Silicone Enteral Feeding Tube - TwistLok - 60cm by 8 French
• 10859950007402: Silicone Enteral Feeding Tube - TwistLok - 60cm by 6.5 French
• 10859950007396: Silicone Enteral Feeding Tube - TwistLok - 60cm by 5 French
• 10859950007389: Silicone Enteral Feeding Tube - TwistLok - 40cm by 8 French
• 10859950007372: Silicone Enteral Feeding Tube - TwistLok - 40cm by 6.5 French
• 10859950007365: Silicone Enteral Feeding Tube - TwistLok - 40cm by 5 French
• 10859950007358: Polyurethane Enteral Feeding Tube - TwistLok - 42in by 10 French
• 10859950007341: Polyurethane Enteral Feeding Tube - TwistLok - 42in by 8 French
• 10859950007334: Polyurethane Enteral Feeding Tube - TwistLok - 36in by 6.5 French
• 10859950007327: Polyurethane Enteral Feeding Tube - TwistLok - 36in by 5 French
• 10859950007310: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 8 French
• 10859950007303: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 6.5 French
• 10859950007297: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 5 French
• 10859950007280: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 4 French
• 10859950007273: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 8 French
• 00859950007269: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 6.5 French
• 10859950007259: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 5 French
• 00859950007009: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 4 French
• 00859950007238: Polyurethane Enteral Feeding Tube - ENFit - 42in by 10 French
• 10859950007228: Polyurethane Enteral Feeding Tube - ENFit - 42in by 8 French
• 10859950007211: Polyurethane Enteral Feeding Tube - ENFit - 36in by 6.5 French
• 10859950007204: Polyurethane Enteral Feeding Tube - ENFit - 36in by 5 French
• 10859950007198: Polyurethane Enteral Feeding Tube - ENFit - 20in by 8 French
• 10859950007181: Polyurethane Enteral Feeding Tube - ENFit - 20in by 6.5 French
• 00859950007177: Polyurethane Enteral Feeding Tube - ENFit - 20in by 5 French
• 10859950007167: Polyurethane Enteral Feeding Tube - ENFit - 20in by 4 French
• 10859950007150: Polyurethane Enteral Feeding Tube - ENFit - 16in by 8 French
• 10859950007143: Polyurethane Enteral Feeding Tube - ENFit - 16in by 6.5 French
• 10859950007136: Polyurethane Enteral Feeding Tube - ENFit - 16in by 5 French
• 10859950007129: Polyurethane Enteral Feeding Tube - ENFit - 16in by 4 French
• 10859950007112: Polyurethane Enteral Feeding Tube - TwistLok - 42in by 10 French
• 10859950007105: Polyurethane Enteral Feeding Tube - TwistLok - 42in by 8 French
• 10859950007099: Polyurethane Enteral Feeding Tube - TwistLok - 36in by 6.5 French
• 10859950007082: Polyurethane Enteral Feeding Tube - TwistLok - 36in by 5 French
• 10859950007075: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 8 French
• 10859950007068: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 6.5 French
• 10859950007051: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 5 French
• 10859950007044: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 4 French
• 10859950007037: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 8 French
• 10859950007020: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 6.5 French
• 10859950007013: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 5 French
• 10859950007006: Polyurethane Enteral Feeding Tube - TwistLok - 16in by 4 French
• 00858778006812: Silicone Enteral Feeding Tube - ENFit - 40cm by 5 French
• 00858778006805: Silicone Enteral Feeding Tube - ENFit - 40cm by 6.5 French
• 00858778006799: Silicone Enteral Feeding Tube - ENFit - 40cm by 8 French
• 00858778006782: Silicone Enteral Feeding Tube - ENFit - 60cm by 5 French
• 00858778006775: Silicone Enteral Feeding Tube - ENFit - 60cm by 6.5 French