COMPAT® 08741800

GUDID 20043900950680

COMPAT® 18FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok Strap

NESTLE HEALTHCARE NUTRITION, INC.

Gastrostomy tube

• Primary Device ID: 20043900950680
• NIH Device Record Key: 2109b084-7f8d-4002-a13d-c78287423829
• Commercial Distribution Discontinuation: 2019-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: COMPAT®
• Version Model Number: N/A
• Catalog Number: 08741800
• Company DUNS: 829712640
• Company Name: NESTLE HEALTHCARE NUTRITION, 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: 1-877-338-4238
• Email: xxx@xx.xx

Device Dimensions

• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10043900950676 [Primary]
GS1	20043900950680 [Package]; Contains: 10043900950676; Package: Box [5 Units]; Discontinued: 2019-01-11; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K885339

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: 6
• Public Version Date: 2020-04-20
• Device Publish Date: 2015-10-16

On-Brand Devices [COMPAT®]

• 10043900950584: COMPAT® Gastrotube 22FR ENFit™ Connector
• 10043900950553: COMPAT® Gastrotube 20FR ENFit™ Connector
• 10043900950348: COMPAT® Gastrotube 16FR ENFit™ Connector
• 20043900950772: COMPAT® 24FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok St
• 20043900950741: COMPAT® 22FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok St
• 20043900950710: COMPAT® 20FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok St
• 20043900950680: COMPAT® 18FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok St
• 20043900950659: COMPAT® 16FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok St
• 20043900950628: COMPAT® 14FR Replacement Balloon Gastrostomy Tube with Universal "Y" Adapter and Stretch Lok St
• 10043900950522: COMPAT® Gastrotube 24FR ENFit™ Connector
• 10043900950492: COMPAT® Gastrotube 18FR ENFit™ Connector
• 10043900950461: COMPAT® Gastrotube 14FR ENFit™ Connector