COMBI *M sensor 82 0605000

GUDID 05700693095189

COMBI *M sensor 82

Radiometer Basel AG

Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor

• Primary Device ID: 05700693095189
• NIH Device Record Key: c77f0260-8f32-4539-9ef9-ef122a55db88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMBI *M sensor 82
• Version Model Number: 0605000
• Catalog Number: 0605000
• Company DUNS: 481337657
• Company Name: Radiometer Basel 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700693095189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003943

FDA Product Code

• KLK: Monitor, oxygen, cutaneous, for infant not under gas anesthesia

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: 2016-09-01

Devices Manufactured by Radiometer Basel AG

• 05700693095189 - COMBI *M sensor 82: 2018-07-06COMBI *M sensor 82
• 05700693095189 - COMBI *M sensor 82: 2018-07-06 COMBI *M sensor 82
• 05700693095202 - Supplies for COMBI *M 82: 2018-07-06 Supplies for COMBI *M 82, b0605200ox with 12 pcs.
• 05700693095226 - Application set Neonatal: 2018-07-06 Application set Neonatal
• 05700693095240 - Adhesive rings: 2018-07-06 Adhesive rings, 20mm (4x400)
• 05700693095257 - COMBI electrolyte: 2018-07-06 COMBI electrolyte (verp. 1)
• 05700693095288 - Calibration Gas: 2018-03-29 CAL gas 6 cyl.
• 05700693095219 - Application set: 2018-03-29 Application set
• 05700693095233 - Adhesive rings: 2018-03-29 Adhesive rings, 32mm (4x250)