Oxy2Mask O2/EtCO2 OP-2125-8SLM

GUDID 00620974003205

Oxy2Mask O2/EtCO2 Plus

Southmedic Incorporated

Breathing circuit gas-sampling/monitoring set
Primary Device ID00620974003205
NIH Device Record Key6f119b40-bff3-4e99-b80d-05eee5b6c53d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxy2Mask O2/EtCO2
Version Model NumberOP-2125-8SLM
Catalog NumberOP-2125-8SLM
Company DUNS246848147
Company NameSouthmedic Incorporated
Device Count25
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100620974003205 [Unit of Use]
GS110620974003202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-11
Device Publish Date2023-12-01

On-Brand Devices [Oxy2Mask O2/EtCO2]

00620974003229Oxy2Mask O2/EtCO2 Plus Mask with Microsteam connector
00620974003212Oxy2Mask O2/EtCO2 Plus
00620974003205Oxy2Mask O2/EtCO2 Plus
00620974003182Oxy2Mask O2/EtCO2 Adult Mask with Microsteam connector
00620974003175Oxy2Mask O2/EtCO2 Adult
00620974003168Oxy2Mask O2/EtCO2 Adult
00620974003151Oxy2Mask O2/EtCO2 Adult
00620974003137Oxy2Mask O2/EtCO2 Kid Mask with Microsteam connector
00620974003120Oxy2Mask O2/EtCO2 Kid
00620974003687Oxy2Mask O2/EtCO2 Plus

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