AMT Bridle™ Pro E4-421618, 4-421618

GUDID 00842071115937

16 - 18 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive

• Primary Device ID: 00842071115937
• NIH Device Record Key: 8606a6f6-1a84-48ba-b321-45d09b333409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Bridle™ Pro
• Version Model Number: E4-421618
• Catalog Number: E4-421618, 4-421618
• 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
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Dimensions

• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French
• Catheter Gauge: 16 French
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071115890 [Primary]
GS1	00842071115937 [Package]; Contains: 00842071115890; Package: Box (4-421618) [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-12-30

On-Brand Devices [AMT Bridle™ Pro]

• 00842071115937: 16 - 18 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
• 00842071115920: 12 - 14 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
• 00842071115913: 8 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
• 00842071115906: 5 - 6 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)