FDA.reportPublic FDA data

Vital Signs™

Primary DI
10190752125582
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
2025248-001
Catalog number
2025248-001
Device description
Cardiac Output Care Cable for GE Monitors, 3.6 m/12 ft
Published
2018-11-23
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, Fiber-Optic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752125582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075212558210190752125582

GMDN Terms#

Term, Definition table
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#

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
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
10889483586655AirLife™5570715005570715002025-04-02

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Primary DI, Brand, Company table
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00690103217728HemoSphereEdwards Lifesciences LLCDQE2025-07-11
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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
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00690103219371SWAN GANZEdwards Lifesciences LLCDQE2024-08-30
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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