Service gas

GUDID 07640121880056

The Service Gas is required for the calibration of the PCO2-part of SenTec TC Sensors. Depending on usage of the SDMS one Service Gas cylinder lasts f

SenTec AG

Transcutaneous blood gas monitoring system
Primary Device ID07640121880056
NIH Device Record Keyad2a90a4-1da3-46e0-89e9-17dfe163a2cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameService gas
Version Model NumberGAS-0812
Company DUNS480797856
Company NameSenTec AG
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.

Device Identifiers

Device Issuing AgencyDevice ID
GS107640121880056 [Primary]
GS117640121880053 [Package]
Package: Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPZOximeter, Ear

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 Date2016-08-31

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