AMT Bridle™ Pro E4-420810, 4-420810

GUDID 00842071115913

8 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive
Primary Device ID00842071115913
NIH Device Record Key41da2bd6-87cd-44c5-822e-6f4d74caff0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Bridle™ Pro
Version Model NumberE4-420810
Catalog NumberE4-420810, 4-420810
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 Gauge10 French
Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071115876 [Primary]
GS100842071115913 [Package]
Contains: 00842071115876
Package: Box (4-420810) [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)

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