FDA.report

Vital Signs™

Primary DI
10190752180109
Brand
Vital Signs™
Company
Vyaire Medical Oy
Model
406551-035
Catalog number
406551-035
Device description
Connector for CAM14 Mactrode™ V7 Gray AHA
Published
2020-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190752116900PreviousGS10
10190752180109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019075211690010190752116900
1019075218010910190752180109

GMDN Terms

TermDefinition
Electrocardiographic electrode connectorA small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1-833-327-3284customersupport@vyaire.com

Regulatory Flags

DUNS number
368457563
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10190752106901Multi-Link™416468-003416468-0032018-11-23
10190752106925Multi-Link™421930-001421930-0012018-11-23

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