Sureline 015101

GUDID 10884521640535

SURELINE 02 PEDIATRIC 25UN

ORIDION MEDICAL 1987 LTD.

Carbon-dioxide-sampling nasal oxygen cannula

• Primary Device ID: 10884521640535
• NIH Device Record Key: 41df49e4-fcca-486e-9c64-ac303f5464f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sureline
• Version Model Number: 015101
• Catalog Number: 015101
• Company DUNS: 600111512
• Company Name: ORIDION MEDICAL 1987 LTD.
• Device Count: 25
• 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: true
• 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: 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
• 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 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521640535 [Primary]
GS1	20884521640532 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012395

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: 6
• Public Version Date: 2020-04-01
• Device Publish Date: 2016-09-25

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• 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