Microstream

GUDID 10884521761261

PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD

Covidien LP

Carbon dioxide monitor

• Primary Device ID: 10884521761261
• NIH Device Record Key: 3dd7f975-296a-48c6-b117-00e8d38ce156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microstream
• Version Model Number: DLPM35MN02-RR
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521761261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200594

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-13
• Device Publish Date: 2022-05-27

On-Brand Devices [Microstream]

• 10884521551992: FILTERLINE H SET ADULT/PEDIATRIC 1 UN
• 10884521551985: FILTERLINE SET ADULT/PEDIATRIC 1 UN
• 30884521551903: ORIDION: SMART CAPNOLINE PLUS O2 ADULT/INT 1 UN
• 10884521591721: SMART CAPNOLINE PLUS O2 LONG A/INT ORI 1 UNIT
• 20884521520797: AC ADAP PKG USA
• 20884521554068: Microstream XXXX
• 10884521799615: CARESCAPE CO2-Microstream Parameter;For use with GE Patient Monitors
• 10884521590809: RS08674
• 10884521815353: Medtronic Microstream (TM) CO2 NanoPod, Philips
• 10884521815346: Medtronic Microstream (TM) CO2 NanoPod
• 10884521844704: Microstream CO2 NanoPod
• 10884521761261: PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD