Oridion

GUDID 10884521520875

RS08251 INFINITY ETCO2MICROSTREAM

ORIDION MEDICAL 1987 LTD.

Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 10884521520875
• NIH Device Record Key: 353ebb99-fa9f-41cb-8a8f-5e80d73248f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oridion
• Version Model Number: RS08251
• Company DUNS: 600111512
• Company Name: ORIDION MEDICAL 1987 LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521520875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123690

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-03
• Device Publish Date: 2022-05-26

Devices Manufactured by ORIDION MEDICAL 1987 LTD.

• 10884521520790 - Microstream: 2024-05-06 AC ADAP PKG USA
• 10884521531512 - Microstream: 2023-12-04 MICROSTREAM ADULT ORAL-NASAL MICROSTREAM FILTERLINE H O2 2M
• 10884521531536 - Microstream: 2023-12-04 MICROSTREAM ADULT-PED INTUBATED MICROSTREAM FILTERLINE H 2M
• 10884521531574 - Microstream: 2023-12-04 MICROSTREAM NEONATAL-INFANT INTUBATED MICROSTREAM FILTERLINE
• 10884521531666 - Microstream: 2023-12-04 MICROSTREAM ADULT ORAL-NASAL MICROSTREAM FILTERLINE 4M 25UN
• 10884521591073 - Microstream: 2023-09-28 RS09489
• 10884521591080 - Microstream: 2023-09-28 RS09603
• 10884521591295 - Microstream: 2023-09-28 Handheld Monitors: Microcap Carrying Case