Surestream 015096COV-05

GUDID 10884521531628

SURESTREAM SURELINE ADULT ORAL-NASAL SAMPLING LINE O2 2M 25

ORIDION MEDICAL 1987 LTD.

Carbon-dioxide-sampling nasal oxygen cannula Carbon-dioxide-sampling nasal oxygen cannula Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 10884521531628
• NIH Device Record Key: 0c03f5e9-58a0-4151-838a-0133f0e92257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surestream
• Version Model Number: 015096COV-05
• Catalog Number: 015096COV-05
• 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
• 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 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none
• Special Storage Condition, Specify: Between 0 and 0 *none

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521531628 [Package]; Contains: 20884521531625; Package: CASE [25 Units]; In Commercial Distribution
GS1	20884521531625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011536

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-22

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• 10884521552227: SURE VENTLINE SET ADULT/PEDIATRIC 25UN
• 10884521552210: SMART SURELINE O2 PEDIATRIC 25UN
• 10884521552203: SURESTREAM SURELINE O2 PEDIATRIC 25UN
• 10884521552166: SMART SURELINE PLUS O2 ADULT 25UN
• 10884521531628: SURESTREAM SURELINE ADULT ORAL-NASAL SAMPLING LINE O2 2M 25
• 20884521552194: Surestream XXXX
• 20884521552156: Surestream XXXX
• 30884521552276: SURESTREAM