Biotronix Healthcare GEED53007

GUDID 10850005165283

Enteral Delivery Gravity Bag Set w/ ENFit™* Connector

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile Enteral feeding kit, adult/paediatric, non-sterile

• Primary Device ID: 10850005165283
• NIH Device Record Key: 38b020cb-09c3-4b2f-ad3b-25c3c4a4f5eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare
• Version Model Number: GEED53007
• Catalog Number: GEED53007
• Company DUNS: 065762392
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, 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: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005165286 [Primary]
GS1	10850005165283 [Package]; Contains: 00850005165286; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181276

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-10-05

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• 20858835007015: Disposable Hypodermic Needle 18G x 1 1/2"
• 20858835007008: Disposable Hypodermic Needles 18G x 1"
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