Entuit Thrive 70-0041-116

GUDID 00827002356160

Entuit Gastrostomy BR Balloon Retention Feeding Tube, 16 FR Ref. Number: SBRD-16

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube

• Primary Device ID: 00827002356160
• NIH Device Record Key: 0c63dc63-109b-495f-ae18-4266e338a1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entuit Thrive
• Version Model Number: EntuitTM Thrive Balloon Retention Gastrostomy Feed
• Catalog Number: 70-0041-116
• Company DUNS: 183325125
• Company Name: XERIDIEM MEDICAL DEVICES, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002356160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130611

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: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2015-06-22

On-Brand Devices [Entuit Thrive]

• 00827002356207: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 24 FR Ref. Number: SBRD-24
• 00827002356191: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 22 FR Ref. Number: SBRD-22
• 00827002356184: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 20 FR Ref. Number: SBRD-20
• 00827002356177: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 18 FR Ref. Number: SBRD-18
• 00827002356160: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 16 FR Ref. Number: SBRD-16
• 00827002356153: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 14 FR Ref. Number: SBRD-14
• 00827002356146: Entuit Gastrostomy BR Balloon Retention Feeding Tube, 12 FR Ref. Number: SBRD-12