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 Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive Nasogastric tube holder, noninvasive
Primary Device ID00842071131111
NIH Device Record Key7552c2f5-669f-42a1-8353-44df492eaf48
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Bridle Pro®
Version Model NumberE4-420810P
Catalog NumberE4-420810P, 4-420810P
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Dimensions

Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French
Catheter Gauge8 French
Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071131081 [Primary]
GS100842071131111 [Package]
Contains: 00842071131081
Package: Box 5 [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-27
Device Publish Date2021-09-17

On-Brand Devices [AMT Bridle Pro®]

008420711311118 - 10 FR AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)
008420711311045 - 6 FR AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)
008420711310988F AMT Bridle Pro® Nasal Tube Retaining System (Pediatric, Pouched)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.