SavEar™ RT-6100

GUDID 10889483228692

SavEar™ Head Band

SUNMED, LLC

Personal device holder, single-use
Primary Device ID10889483228692
NIH Device Record Key99aef4e4-8a43-431f-a323-6341802606cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSavEar™
Version Model NumberRT-6100
Catalog NumberRT-6100
Company DUNS069009268
Company NameSUNMED, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com
Phone1-800-433-2797
Emailinfo@sun-med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078013157 [Previous]
GS110889483228692 [Primary]
GS120889483228699 [Package]
Package: Box [40 Units]
In Commercial Distribution

FDA Product Code

JAYSupport, Breathing Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

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30889483623323 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Tracheostomy, 12 F, WET PAK™
30889483623347 - BALLARD™2026-02-06 BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Endotracheal, 12 F

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