N/A 403751-009

GUDID 10190752106529

ECG Leadwire, DIN, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in

AirLife Finland Oy

Radiolucent electrocardiographic lead
Primary Device ID10190752106529
NIH Device Record Key4b797ad1-b020-43bd-a13f-8c7458aa36b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number403751-009
Catalog Number403751-009
Company DUNS368457563
Company NameAirLife Finland Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com
Phone1-833-327-3284
Emailcustomersupport@vyaire.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110190752106529 [Primary]

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-12-04
Device Publish Date2018-11-23

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10889483582039 - Multi-Link™2025-04-11 ECG Leadwire, DIN, Radiolucent, 5-lead, Grabber, AHA, 150 cm/59 in
10889483582053 - Multi-Link™2025-04-11 Multi-Link™ ECG Leadwire, Radiolucent, 5-lead, Grabber, AHA, 150 cm/59 in
10889483582060 - Multi-Link™2025-04-11 Multi-Link™ ECG Leadwire, Radiolucent, 12-lead, Grabber, AHA, 150 cm/59 in
10889483582077 - Multi-Link™2025-04-11 Multi-Link™ ECG Leadwire, Radiolucent, 5-lead, Grabber, IEC, 150 cm/59 in
10889483582084 - Multi-Link™2025-04-11 Multi-Link™ ECG Leadwire, Radiolucent, 12-lead, Grabber, IEC, 150 cm/59 in

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