AMT Bridle Pro™ Spare Clip E4-461214, 4-461214

GUDID 00842071119546

12F - 14F AMT Bridle Pro™ Spare Clip (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive

• Primary Device ID: 00842071119546
• NIH Device Record Key: 8a35afb8-eb01-4453-ba0b-8c81a729d453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Bridle Pro™ Spare Clip
• Version Model Number: E4-461214
• Catalog Number: E4-461214, 4-461214
• 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: 12 French
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071119546 [Primary]
GS1	00842071119560 [Package]; Package: Box [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: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-10-19

On-Brand Devices [AMT Bridle Pro™ Spare Clip]

• 00842071119553: 16F - 18F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071119546: 12F - 14F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118334: 18F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118327: 16F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118310: 14F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118303: 12F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118297: 10F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118280: 8F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118136: 8F - 10F AMT Bridle Pro™ Spare Clip (Pouched)
• 00842071118266: 5F - 6F AMT Bridle Pro™ Spare Clip (Pouched)