AMT Bridle Pro™ E4-4218, 4-4218

GUDID 00842071118259

18F AMT Bridle Pro™ Nasal Tube Retaining System (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Nasogastric tube holder, noninvasive
Primary Device ID00842071118259
NIH Device Record Keyecb5430a-6417-4bdb-a299-ed4e3e9155a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Bridle Pro™
Version Model NumberE4-4218
Catalog NumberE4-4218, 4-4218
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 Gauge18 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071118112 [Primary]
GS100842071118259 [Package]
Contains: 00842071118112
Package: Box (4-4218) [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)

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