AMT Micro Bridle™ Spare Clip E4-4508M, 4-4508M

GUDID 00842071111533

8F AMT Micro Bridle Spare Clip (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive

• Primary Device ID: 00842071111533
• NIH Device Record Key: edf1bedb-0d85-43bd-8c21-579a906dcbf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Micro Bridle™ Spare Clip
• Version Model Number: E4-4508M
• Catalog Number: E4-4508M, 4-4508M
• 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: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071104023 [Primary]
GS1	00842071111533 [Package]; Contains: 00842071104023; Package: Box (4-4508M) [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™ Spare Clip]

• 00842071111533: 8F AMT Micro Bridle Spare Clip (Pouched)
• 00842071111519: 6F AMT Micro Bridle Spare Clip (Pouched)
• 00842071111502: 5F AMT Micro Bridle Spare Clip (Pouched)