FDA.reportPublic FDA data

Vital Signs

Primary DI
10885403257414
Brand
Vital Signs
Company
Carefusion Finland 320 Oy
Model
9446-909
Catalog number
9446-909
Device description
Cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft
Published
2016-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECATHETER, OXIMETER, FIBEROPTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403257414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540325741410885403257414

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(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
367919120
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403252051Multi-Link2052104-0052052104-0052016-09-14
10885403252068Multi-Link2052104-0062052104-0062016-09-14
10885403252075Multi-Link2052104-0072052104-0072016-09-14
10885403252082Multi-Link2052104-0082052104-0082016-09-14
10885403252112Multi-Link2052133-0052052133-0052016-09-14
10885403252129Multi-Link2052133-0062052133-0062016-09-14
10885403252136Multi-Link2052133-0072052133-0072016-09-14
10885403252143Multi-Link2052133-0082052133-0082016-09-14
10885403256837Multi-Link2086349-0032086349-0032016-09-14
10885403256844Multi-Link2086349-0042086349-0042016-09-14
10885403256875Multi-Link2086367-0032086367-0032016-09-14
10885403256882Multi-Link2086367-0042086367-0042016-09-14
10885403417436Multi-Link2052104-0272052104-0272016-09-14
10885403417450Multi-Link2052133-0272052133-0272016-09-14
10190752100015Multi-Link™2090101-0502090101-0502017-07-11
10190752100022Multi-Link™2090101-0602090101-0602017-07-11
10190752100046Multi-Link™2090101-0802090101-0802017-07-11
10190752100084Multi-Link™2090101-5112090101-5112017-07-11
10190752100107Multi-Link™2090101-5122090101-5122017-07-11
10190752100121Multi-Link™2090101-5132090101-5132017-07-11

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