VentiSure2

GUDID 10841470105294

ENGINEERED MEDICAL SYSTEMS INC

Pulmonary resuscitator, manual, single-use
Primary Device ID10841470105294
NIH Device Record Key0ef6eabb-1da2-4302-b88e-4372d5fdd141
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentiSure2
Version Model Number301-5818
Company DUNS154502934
Company NameENGINEERED MEDICAL SYSTEMS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-246-5500
Emailinfo@engmedsys.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470105297 [Primary]
GS110841470105294 [Package]
Contains: 00841470105297
Package: [8 Units]
In Commercial Distribution

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 Number4
Public Version Date2019-11-11
Device Publish Date2016-09-30

On-Brand Devices [VentiSure2]

10841470106956301-5802
10841470105430301-5911
10841470105423301-5740
00841470105419301-5679
10841470105409301-5810
00841470105396301-5735
10841470105386301-5812
10841470105379301-5803
10841470105362301-5742
10841470105355301-5581
10841470105348301-5678
10841470105331301-5580
10841470105324301-5800
10841470105317301-5726
10841470105300301-5736
10841470105294301-5818
10841470105287301-5582
10841470105270301-5734
10841470105263301-5680
10841470105256301-5811
10841470105249301-5739
10841470105232301-5813
10841470105225301-5677
10841470105218301-5579
10841470105195301-5737
10841470105201301-5817

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