FDA.reportPublic FDA data

Echo CO2

Primary DI
00815871021340
Brand
Echo CO2
Company
Avante
Model
60129MC
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101539000VITAL SIGNS MONITOR MODEL M3BEdan Instruments, Inc.2010-11-24DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815871021340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871021340008158710213408158710213400815871021340

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood gas, transcutaneousA small unit dedicated to the measurement of blood gas tensions for the partial pressure of oxygen (pO2) and partial pressure of carbon dioxide (pCO2) transcutaneously (through the skin) in a patient's blood using a special sensor which is typically heated to improve local vascularity. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pO2/pCO2 signals measured and provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-244-4444devicehelp@dremed.com

Regulatory Flags#

DUNS number
178440426
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815871021647VISION LEDDRE 0615122016-09-23
00815871021685VISION LEDDRE 061512-V2016-09-23
00815871021722VISION EX5DRE 0614122016-09-23
00815871021807Vista LEDDRE 0613122016-09-23
00815871021845Vista LEDDRE 061312-V2016-09-23
00815871022163VISION LEDDRE 0615222017-01-31
00815871022200VISION LEDDRE 061522-V2017-02-01
00815871022248VISION EX5DRE 0614222017-02-01
00815871022286VISION EX5DRE 061422-V2017-02-01
00815871022323Vista LEDDRE 0613222017-02-01
00815871022361Vista LEDDRE 061322-V2017-02-01
00815871020008ASG 12071250ASG2016-09-23
00815871020015ASG 12071250ASGR2016-09-23
00815871020022ASG 2007200ASG2016-09-23
00815871020039ASG 2007200ASGR2016-09-23
00815871020046ASG 3007300ASG2016-09-23
00815871020053ASG 3007300ASGR2016-09-23
00815871021432EG-30070300MB2016-09-23
00815871021449EG-Pro70S4002016-09-23
00815871020107Nasal CO2 Sampling Cannula With O2 DeliveryP03082D2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
06946725516188APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516195APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516201APKAPK Technology Co.,Ltd.DQA2026-03-11
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06946725516225APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516232APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516249APKAPK Technology Co.,Ltd.DQA2026-03-11
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06946725516300APKAPK Technology Co.,Ltd.DQA2026-03-11
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06946725516454APKAPK Technology Co.,Ltd.DQA2026-03-11