Vital Signs™

Primary DI
10190752181380
Brand
Vital Signs™
Company
Vyaire Medical Oy
Model
9446-911
Catalog number
9446-911
Device description
Cardiac output in-line injectate probe for GE monitors, Merit Medical CritiKit, 0.9 m/3 ft
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECatheter, Oximeter, Fiber-Optic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752125629PreviousGS10
10190752181380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075212562910190752125629
1019075218138010190752181380

GMDN Terms#

Term, Definition table
TermDefinition
Injectate temperature probeA non-sterile, non-patient contact device intended to be connected to a parent temperature display/monitor (not included) to measure the temperature of a vascular injectate solution (and/or injectate cooling bath) prior to its introduction into the vasculature (e.g., as part of thermodilution-based cardiac output monitoring); it is not intended to contact the injectate directly. It is typically a metal probe with a sensor and connection cable. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10190752106543Multi-Link™411200-002411200-0022018-11-23
10190752106574Multi-Link™411200-005411200-0052018-11-23
10190752106581Multi-Link™411202-001411202-0012018-11-23
10190752106598Multi-Link™411202-002411202-0022018-11-23
10190752106628Multi-Link™411202-005411202-0052018-11-23
10190752106642Multi-Link™411203-001411203-0012018-11-23
10190752106659Multi-Link™411203-002411203-0022018-11-23
10190752106680Multi-Link™412681-001412681-0012018-11-23
10190752106697Multi-Link™412681-002412681-0022018-11-23
10190752106741Multi-Link™412682-001412682-0012018-11-23
10190752106758Multi-Link™412682-002412682-0022018-11-23
10190752106789Multi-Link™414556-001414556-0012018-11-23
10190752106796Multi-Link™414556-002414556-0022018-11-23
10190752106826Multi-Link™414556-005414556-0052018-11-23
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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