Multi-Link™ 2086367-005

GUDID 20190752182353

Multi-Link™ X2 Single-Patient-Use Long ECG Leadwire Set, 6-Lead Set, Grabber, IEC, 3.6 m/12 ft

Vyaire Medical Oy

Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use Electrocardiographic lead set, single-use

• Primary Device ID: 20190752182353
• NIH Device Record Key: 842b2937-8bd2-4432-b7d7-6c90986ee933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Link™
• Version Model Number: 2086367-005
• Catalog Number: 2086367-005
• Company DUNS: 368457563
• Company Name: Vyaire Medical Oy
• 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: true
• Expiration Date: false
• 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: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752182356 [Primary]
GS1	20190752182353 [Package]; Contains: 10190752182356; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• DSA: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

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• 20190752141015: Single-Patient-Use ECG Leadwire Set 3-LEAD, SNAP, AHA, 75 cm/29 in
• 20190752140988: Single-Patient-Use ECG Leadwire Set 5-LEAD, SNAP, AHA, 75 cm/29 in
• 20190752140971: Single-Patient-Use ECG Leadwire Set 5-LEAD, SNAP, AHA, 100 cm/39 in
• 20190752140964: Single-Patient-Use ECG Leadwire Set 3-LEAD, SNAP, AHA, 100 cm/39 in
• 10190752135628: Maternal/Fetal ECG Y Adapter Cable for Corometrics™
• 20190752182247: X2 Single-Patient-Use Long ECG Leadwire Set 3-Lead Set, Snap, AHA, 3.6m/ 12 ft
• 10190752182158: Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Round Connector, 2.
• 10190752182141: Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Rectangular Connec
• 10190752182134: Maternal/Fetal ECG Y Adapter Cable for Corometrics™
• 10190752181021: ECG Leadwire 6-lead, Grabber, AHA, 74 cm/29 in & 130 cm/51 in
• 10190752181014: ECG Leadwire 6-lead, Grabber, AHA, 130 cm/51 in
• 10190752181007: ECG Leadwire 6-lead, Grabber, AHA, 74 cm/29 in
• 10190752180970: ECG Leadwire 6-lead, Snap, AHA, 74 cm/29 in & 130 cm/51 in
• 10190752180963: ECG Leadwire 6-lead, Snap, AHA, 130 cm/51 in
• 10190752180956: ECG Leadwire 6-lead, Snap, AHA, 74 cm/29 in
• 10190752180932: ECG Leadwire V-lead, Snap, AHA, 74 cm/29 in
• 10190752180918: ECG Leadwire V-lead, Snap, AHA, 130 cm/51 in
• 10190752180895: ECG Leadwire V-lead, Grabber, AHA, 74 cm/29 in
• 10190752180871: ECG Leadwire V-lead, Grabber, AHA, 130 cm/51 in
• 10190752180864: ECG Leadwire, Individual Replacement, Purple V6, Grabber, AHA, 74cm/29in
• 10190752180857: ECG Leadwire, Individual Replacement, Orange V5, Grabber, AHA, 74cm/29in
• 10190752180840: ECG Leadwire, Individual Replacement, Blue V4, Grabber, AHA, 74cm/29in
• 10190752180833: ECG Leadwire, Individual Replacement, Green V3, Grabber, AHA, 74 cm/29 in
• 10190752180826: ECG Leadwire, Individual Replacement, Yellow V2, Grabber, AHA, 74cm / 29in
• 10190752180789: ECG Leadwire Replaceable Set, 5-lead, Grabber, AHA, 74 cm/29 in & 130 cm/51 in
• 10190752180758: ECG Leadwire Replaceable Set, 5-lead, Grabber, AHA, 130 cm/51 in
• 10190752180741: ECG Leadwire Replaceable Set, 5-lead, Grabber, AHA, 74 cm/29 in
• 10190752180734: DIN Converter, 3-Lead
• 10190752180727: DIN Converter, 12-Lead
• 10190752180710: DIN Converter, 5-Lead
• 10190752180703: ECG Care Cable 3/5-Lead, AHA, 6 m/20 ft
• 10190752180673: ECG Leadwire 3-lead, Grabber, AHA, 130 cm/51 in
• 10190752180666: ECG Leadwire 3-lead, Grabber, AHA, 74 cm/29 in
• 10190752180611: ECG Leadwire Grouped Set, 5-lead, Grabber, AHA, 130 cm/51 in
• 10190752180604: ECG Leadwire Grouped Set, 5-lead, Grabber, AHA, 74 cm/29 in
• 10190752180543: ECG Leadwire, Individual Replacement, Brown V, Grabber, AHA, 130cm/51in
• 10190752180536: ECG Leadwire, Individual Replacement, Black LA, Grabber, AHA, 130cm/51in
• 10190752180529: ECG Leadwire, Individual Replacement, Green RL, Grabber, AHA, 130cm/51in
• 10190752180512: ECG Leadwire, Individual Replacement, White RA, Grabber, AHA, 130cm/51in
• 10190752180505: ECG Leadwire, Individual Replacement, Red LL, Grabber, AHA, 130cm/51in
• 10190752180444: ECG Leadwire, Individual Replacement, Brown V, Grabber, AHA, 74cm/29in
• 10190752180437: ECG Leadwire, Individual Replacement, Black LA, Grabber, AHA, 74cm/29in
• 10190752180420: ECG Leadwire, Individual Replacement, Green RL, Grabber, AHA, 74cm/29in
• 10190752180413: ECG Leadwire, Individual Replacement, White RA, Grabber, AHA, 74cm/29in
• 10190752180406: ECG Leadwire, Individual Replacement, Red LL, Grabber, AHA, 74cm/29in
• 10190752180390: ECG Leadwire, Individual Replacement, Brown V, Snap, AHA, 130cm/51in
• 10190752180383: ECG Leadwire, Individual Replacement, Black LA, Snap, AHA, 130cm/51in