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 ID: 07640121880056
• NIH Device Record Key: ad2a90a4-1da3-46e0-89e9-17dfe163a2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Service gas
• Version Model Number: GAS-0812
• Company DUNS: 480797856
• Company Name: SenTec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C (122°F).
• Special Storage Condition, Specify: Between 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 Agency	Device ID
GS1	07640121880056 [Primary]
GS1	17640121880053 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041548

FDA Product Code

• DPZ: Oximeter, Ear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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