AMT Micro Bridle™ E4-4105M, 4-4105M

GUDID 00842071106607

5F AMT Micro Bridle Nasal Tube Retaining System (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive

• Primary Device ID: 00842071106607
• NIH Device Record Key: 6890efce-6c78-4180-9e50-2b516dd84d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Micro Bridle™
• Version Model Number: E4-4105M
• Catalog Number: E4-4105M, 4-4105M
• 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

Device Dimensions

• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071103903 [Primary]
GS1	00842071106607 [Package]; Contains: 00842071103903; Package: Box (4-4105M) [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: 2016-08-31

On-Brand Devices [AMT Micro Bridle™]

• 00842071106638: 8F AMT Micro Bridle Nasal Tube Retaining System (Pouched)
• 00842071106614: 6F AMT Micro Bridle Nasal Tube Retaining System (Pouched)
• 00842071106607: 5F AMT Micro Bridle Nasal Tube Retaining System (Pouched)