SMART BAG MO 01`BM3211-MO-CS

GUDID 17540195000145

The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating bag, a one way valve and a face mask designed to suppl

O-Two Medical Technologies Inc

Pulmonary resuscitator, manual, single-use
Primary Device ID17540195000145
NIH Device Record Keyb5776e40-404f-4257-a9bd-85e2117f8c1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMART BAG MO
Version Model Number01BM3211-MO
Catalog Number01`BM3211-MO-CS
Company DUNS206449154
Company NameO-Two Medical Technologies 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

Phone1-800-387-3405
Emailcs@otwo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195000148 [Primary]
GS117540195000145 [Package]
Contains: 07540195000148
Package: Corrugated carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

On-Brand Devices [SMART BAG MO]

17540195000220The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000206The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
07540195000186The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000145The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
07540195000124The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000107The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000084The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
07540195000025The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000497The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000480The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000237The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating

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