Legend

GUDID 04719872109068

ENTER MEDICAL CORPORATION

Pulmonary resuscitator, manual, reusable
Primary Device ID04719872109068
NIH Device Record Key01e0d78c-7542-41eb-bbd1-2a53d0d9731d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLegend
Version Model NumberRMR002R
Company DUNS658833116
Company NameENTER MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872109068 [Primary]

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-14

On-Brand Devices [Legend]

04719872109075RMR003R
04719872109068RMR002R
04719872109051RMR001R

Trademark Results [Legend]

Mark Image

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