Application set Neonatal 0607120

GUDID 05700693095226

Application set Neonatal

Radiometer Basel AG

Transcutaneous blood gas monitor sensor

• Primary Device ID: 05700693095226
• NIH Device Record Key: c93644d9-cd20-42b6-a9f5-fa1dd4544aa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Application set Neonatal
• Version Model Number: 0607120
• Catalog Number: 0607120
• 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: 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

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 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700693095226 [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: 2018-07-06 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: 2018-07-06Application set Neonatal
• 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)