Generica Medical

GUDID 20859261004043

Enteral Delivery System Cross Spike Plus with ENFit

GENERICA MEDICAL INTERNATIONAL

Enteral feeding bag/bottle

• Primary Device ID: 20859261004043
• NIH Device Record Key: daa435fc-9b54-4d8a-b55b-47066e352a7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Generica Medical
• Version Model Number: GMI-2000CSP
• Company DUNS: 078851039
• Company Name: GENERICA MEDICAL INTERNATIONAL
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 909-596-6785
• Email: lh@entechmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859261004063 [Primary]
GS1	20859261004043 [Package]; Contains: 00859261004063; Package: case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133077

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Generica Medical]

• 20859261004029: Enteral Delivery Gravity Bag Set with ENFit
• 20859261004036: Enteral Pump Bag Bag Set with ENFit
• 20859261004050: 60cc Irrigation Syringe with ENFit
• 20859261004043: Enteral Delivery System Cross Spike Plus with ENFit