Microstream 015771

GUDID 20884521551845

SMART CAPNOLINE PLUS LONG 1UN

ORIDION MEDICAL 1987 LTD.

Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 20884521551845
• NIH Device Record Key: 564bf520-c496-41e5-920d-75e4e5bd0a57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microstream
• Version Model Number: 015771
• Catalog Number: 015771
• Company DUNS: 600111512
• Company Name: ORIDION MEDICAL 1987 LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521551848 [Primary]
GS1	20884521551845 [Package]; Contains: 10884521551848; Package: CASE [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980325

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: 4
• Public Version Date: 2022-03-22
• Device Publish Date: 2017-11-09

On-Brand Devices [Microstream]

• 10884521592469: MICROSTREAM PAIN MANAGEMENT SAMPLE PAK
• 10884521552425: CapnoLine H O2 Adult CO2 Nasal Sampling Set with O2 Tubing for Long Term Use
• 10884521552418: FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adaptor for Humid Environments
• 10884521552395: VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adaptor for High Ambient Humidity
• 20884521552378: SMART CAPNOLINE PLUS O2 LG ADU/INT 25UN M.ISRAEL
• 20884521552361: SMART CAPNOLINE GUARDIAN O2, 25 UN M.ISRAEL
• 10884521552340: FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter
• 10884521552333: SMART CAPNOLINE GUARDIAN O2 LG 25 UN M.ISRAEL
• 10884521552319: Smart CapnoLine Plus O2 Adult/Intermediate CO2 Oral/Nasal Sampling Set with O2 Tubing
• 10884521552302: MICROSTREAM SMART CAPNOLINE H PLUS O2 25 UN ORD M.ISRAEL
• 10884521552296: MICROSTREAM FILTERLINE H SET ADU/PED 25UN ORIDION M.ISRAEL
• 10884521551916: SMART CAP+ O2 LG ADU/INT (25)
• 10884521531635: MICROSTREAM ADULT ORAL-NASAL MICROSTREAM FILTERLINE O2 4M 25
• 10884521531604: MICROSTREAM ADULT ORAL-NASAL MICROSTREAM FILTERLINE 2M 25UN
• 10884521531567: MICROSTREAM PEDIATRIC ORAL-NASAL MICROSTREAM FILTERLINE O2 2
• 10884521531550: MICROSTREAM ADULT-PED BITE BLOCK MICROSTREAM FILTERLINE 02 2
• 30884521216017: FTL H SET LONG INF/NEO 1 UN ORIDION
• 10884521619340: CARIL VITALINE INF/NEO SET 1UN
• 20884521591698: FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter
• 10884521548404: MICROSTREAM Capnostream35 External Charger
• 10884521551497: CAPNOSTREAM 20P (INTL) N - ROHS
• 10884521551473: CAPNOSTREAM 20P (INTL) N W/PRINTER
• 10884521551466: CAPNOSTREAM 20P (INTL) N
• 10884521761216: PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD
• 10884521551596: Microstream XXXX
• 10884521551589: MICROSTREAM CAPNOSTREAM 35 PORTABLE RESPIRATORY MONITOR(EURO
• 10884521591745: CAPNOSTREAM 35 PORTABLE RESPIRATORY MONITOR-BRAZIL
• 10884521551978: 015183
• 10884521551503: CAPNOSTREAM 20P (US) N W/PRINTER - ROHS
• 10884521551480: CAPNOSTREAM 20P (US) N - ROHS
• 10884521551398: Microstream XXXX
• 10884521807198: CS78651
• 10884521592452: MILITARY / AIR MEDICAL FL SAMPLEPAK
• 10884521209213: Used CS20P (US) N W/PRINTER, DS
• 10884521591332: MSM INTF KIT PKG
• 10884521551510: CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS
• 10884521591226: HANDHELD RECHARGEABLE BATTERY PACK
• 10884521554115: MICROSTREAM CAPNOLINE H INF/NEO LONG 1UN
• 20884521551869: CAPNOLINE H INF/NEO 1 UN ORI
• 20884521551838: NIV LINE PED 1 UN ORI
• 10884521593312: Starter Kit Pediatric
• 10884521593305: Starter Kit Adult
• 20884521552408: 015310 Microstream
• 20884521552255: Microstream XXXX
• 30884521552146: SMART CAPNOLINE GUARDIAN O2, 1 UN
• 30884521552115: SMART CAPNOLINE GUARDIAN O2 LONG, 1 UN
• 20884521554136: MICROSTREAM SMART CAPNOLINE GUARDIAN, 1 UN
• 20884521552071: Microstream XXXX
• 20884521552064: Microstream XXXX
• 10884521554108: SP00014977