AMT Bridle Pro™ E4-4214, 4-4214

GUDID 00842071118235

14F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive
Primary Device ID00842071118235
NIH Device Record Keya986d737-f2ca-4a4b-b012-40f911c5c45a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Bridle Pro™
Version Model NumberE4-4214
Catalog NumberE4-4214, 4-4214
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

Device Dimensions

Catheter Gauge14 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071118099 [Primary]
GS100842071118235 [Package]
Contains: 00842071118099
Package: Box (4-4214) [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-22
Device Publish Date2017-06-16

On-Brand Devices [AMT Bridle Pro™]

0084207111825918F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)
0084207111824216F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)
0084207111823514F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)
0084207111822812F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)
0084207111821110F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)
008420711182048F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)

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