ETCO2 Sensor

GUDID 06970706360668

Respironics Compatible, Mainstream, 3.0M

Orantech Inc.

Carbon dioxide monitor
Primary Device ID06970706360668
NIH Device Record Keyc92509fb-7530-4c0a-b905-478246a1606b
Commercial Distribution StatusIn Commercial Distribution
Brand NameETCO2 Sensor
Version Model NumberCTM-RP01
Company DUNS544423370
Company NameOrantech 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970706360668 [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 Date2021-01-04
Device Publish Date2020-12-25

Devices Manufactured by Orantech Inc.

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06941691983996 - Orantech 2025-07-21 Spacelabs Compatible,Use with conte, 1.5M
06941691918431 - Orantech 2024-12-25 Pronk Compatible,Use with DC3.5, 1.5M
06941691919025 - Orantech 2024-12-25 Philips Compatible,Use with MD6M, 1.5M
06941691919094 - Orantech 2024-12-25 AAMI 6Pins Compatible, use with MD6M Pressure Transducer,1.5m

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