Ventline 015102

GUDID 10884521640542

SURE VENTLINE SET ADULT / PEDIATRIC SAMPLING LINE (25 UNITS)

ORIDION MEDICAL 1987 LTD.

Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 10884521640542
• NIH Device Record Key: a406648f-d3b3-47ca-bc1c-ba65897dce75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventline
• Version Model Number: 015102
• Catalog Number: 015102
• 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

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	10884521640542 [Primary]
GS1	20884521640556 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980324

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: 5
• Public Version Date: 2020-04-01
• Device Publish Date: 2016-09-25

On-Brand Devices [Ventline]

• 10884521640559: SURE VENTLINE SET H ADULT / PEDIATRIC SAMPLING LINE (25 UNITS)
• 10884521640542: SURE VENTLINE SET ADULT / PEDIATRIC SAMPLING LINE (25 UNITS)