AMT Bridle™ Pro E4-420506, 4-420506

GUDID 00842071115906

5 - 6 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive
Primary Device ID00842071115906
NIH Device Record Key59ab2903-2903-4761-94e6-bcdde8e29c08
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Bridle™ Pro
Version Model NumberE4-420506
Catalog NumberE4-420506, 4-420506
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 Gauge5 French
Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071115869 [Primary]
GS100842071115906 [Package]
Contains: 00842071115869
Package: Box (4-420506) [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 Date2016-12-30

On-Brand Devices [AMT Bridle™ Pro]

0084207111593716 - 18 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
0084207111592012 - 14 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
008420711159138 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
008420711159065 - 6 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)

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