Mini StatCO2 End Tidal CO2 Detector

GUDID 10641043553718

MERCURY ENTERPRISES, INC.

Exhaled-gas oesophageal intubation detector, paediatric
Primary Device ID10641043553718
NIH Device Record Key328fd039-8c55-4e1a-b467-640cb9ef0beb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini StatCO2 End Tidal CO2 Detector
Version Model Number10-55371
Company DUNS032705659
Company NameMERCURY ENTERPRISES, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110641043553718 [Primary]
GS130641043553712 [Package]
Package: [20 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-18
Device Publish Date2016-01-08

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