MRVLS 572808

GUDID 17290102590015

MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)

Elecam Medical Agricultural Cooperative Society Ltd.

Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock Stopcock

• Primary Device ID: 17290102590015
• NIH Device Record Key: ad23544e-2c78-4219-af8b-1ca28c514765
• Commercial Distribution Discontinuation: 2018-05-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MRVLS
• Version Model Number: NA
• Catalog Number: 572808
• Company DUNS: 532599255
• Company Name: Elecam Medical Agricultural Cooperative Society Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• 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: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il
• Phone: +97246988120
• Email: sales@elcam.co.il

Device Dimensions

• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal
• Pressure: 200 KiloPascal

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290102590018 [Primary]
GS1	17290102590015 [Package]; Contains: 07290102590018; Package: dispenser [45 Units]; Discontinued: 2018-05-09; Not in Commercial Distribution
GS1	27290102590012 [Package]; Package: Carton box [6 Units]; Discontinued: 2018-05-09; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060231

FDA Product Code

• FMG: Stopcock, I.V. Set

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-09-24

Devices Manufactured by Elecam Medical Agricultural Cooperative Society Ltd.

• 17290102590213 - A-TAP: 2024-02-06 A-TAP BLS RAD
• 17290102590015 - MRVLS: 2018-10-29MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)
• 17290102590015 - MRVLS: 2018-10-29 MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)
• 27290102590029 - STP 4WAY RAD: 2018-10-29 STP 4WAY RAD
• 27290102590036 - STP 1 WAY RAD: 2018-10-29 STP 1 WAY RAD