AMT Bridle Pro® E4-420810P, 4-420810P

GUDID 00842071131111

8 - 10 FR AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive

• Primary Device ID: 00842071131111
• NIH Device Record Key: 7552c2f5-669f-42a1-8353-44df492eaf48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Bridle Pro®
• Version Model Number: E4-420810P
• Catalog Number: E4-420810P, 4-420810P
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French
• Catheter Gauge: 8 French
• Catheter Gauge: 10 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071131081 [Primary]
GS1	00842071131111 [Package]; Contains: 00842071131081; Package: Box 5 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030784

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-27
• Device Publish Date: 2021-09-17

On-Brand Devices [AMT Bridle Pro®]

• 00842071131111: 8 - 10 FR AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)
• 00842071131104: 5 - 6 FR AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)
• 00842071131098: 8F AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)