Silicone Stomach Tube

GUDID 04710961936381

FORTUNE MEDICAL INSTRUMENT CORP.

Nasogastric feeding tube

• Primary Device ID: 04710961936381
• NIH Device Record Key: cb965a1c-cdd5-4d3c-9479-a76b09a0cc0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Stomach Tube
• Version Model Number: 2020-0016
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 10
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710961936381 [Primary]
GS1	14710961936388 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022112

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: 2016-03-15

On-Brand Devices [Silicone Stomach Tube]

• 04711182605407: 2020-0005
• 04711182605391: 2020-0004
• 04710961936404: 2020-0020
• 04710961936398: 2020-0018
• 04710961936381: 2020-0016
• 04710961936374: 2020-0014
• 04710961936367: 2020-0012
• 04710961936350: 2020-0010
• 04710961936343: 2020-0008
• 04710961936336: 2020-0006