FDA.report

Vital Signs™

Primary DI
10190752179059
Brand
Vital Signs™
Company
Vyaire Medical Oy
Model
2016995-001
Catalog number
2016995-001
Device description
Invasive Blood Pressure Cable, For use with Merit Medical Meritrans DTXPlus, Single, 3.6 m/12 ft.
Published
2020-12-01
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
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications

CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190752113688PreviousGS10
10190752179059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019075211368810190752113688
1019075217905910190752179059

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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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10190752106840Multi-Link™416467-001416467-0012018-11-23
10190752106864Multi-Link™416467-003416467-0032018-11-23
10190752106888Multi-Link™416468-001416468-0012018-11-23
10190752106901Multi-Link™416468-003416468-0032018-11-23
10190752106925Multi-Link™421930-001421930-0012018-11-23

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