FDA.reportPublic FDA data

Vital Signs™

Primary DI
10190752181366
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
9446-909
Catalog number
9446-909
Device description
Cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
10190752125605PreviousGS10
10190752181366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075212560510190752125605
1019075218136610190752181366

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
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752140912Vital Signs™M1031274M10312742021-01-28
10190752145641Vital Signs™M1031273M10312732021-07-06
10190752191235Vital Signs™M1031274M10312742023-05-30
10190752125582Vital Signs™2025248-0012025248-0012018-11-23
10190752125599Vital Signs™2025248-0022025248-0022018-11-23
10190752125629Vital Signs™9446-9119446-9112018-11-23
10190752125636Vital Signs™9446-9139446-9132018-11-23
10190752181380Vital Signs™9446-9119446-9112020-12-15
10190752181397Vital Signs™9446-9139446-9132020-12-15
10190752179349Vital Signs™2025248-0012025248-0012020-12-01
10190752179356Vital Signs™2025248-0022025248-0022020-12-01
10889483587881AirLife™6600-0196-7006600-0196-7002025-03-26
10889483587904AirLife™6600-0208-7006600-0208-7002025-03-26
10889483590003AirLife™800423180042312025-04-02
10889483590584AirLife™857020385702032025-04-02
10889483601563AirLife™M1010534M10105342025-04-02
10889483602522AirLife™M1038637M10386372025-03-31
10889483603222Vital Signs™M1138830M11388302025-04-02
10889483586549AirLife™5570195005570195002025-04-02
10889483586624AirLife™5570701005570701002025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDQE2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
50690103218621SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
00690103000412SWAN-GANZEdwards Lifesciences LLCDQE2026-01-30
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCDQE2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCDQE2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCDQE2025-09-10
00690103219616ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDQE2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDQE2025-07-11
50690103219611ForeSight IQEdwards Lifesciences LLCDQE2025-07-11
10889483591420Vital Signs™AirLife Finland OyDQE2025-04-02
10889483591437Vital Signs™AirLife Finland OyDQE2025-04-02
00840619046613ICU MedicalICU MEDICAL, INC.DQE2025-03-25
10840619046610ICU MedicalICU MEDICAL, INC.DQE2025-03-25
00690103217957HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDQE2025-03-13
00690103219371SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
50690103219376SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
00690103218879HemoSphere VitaEdwards Lifesciences LLCDQE2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDQE2024-08-28
00690103219388SWAN-GANZEdwards Lifesciences LLCDQE2024-08-05
50690103219383SWAN-GANZEdwards Lifesciences LLCDQE2024-08-05
00690103217124HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCDQE2024-02-26