FDA.report

Vital Signs™

Primary DI
10889483576274
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
2021197-003
Catalog number
2021197-003
Device description
Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Dual, 3.6 m/12 ft.
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10190752179288PreviousGS10
10889483576274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019075217928810190752179288
1088948357627410889483576274

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
(800)433-2797info@sun-med.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 DIBrandModelCatalogPublished
10889483575901Multi-Link™2017005-0032017005-0032025-04-22
20889483576493Vital Signs™2030887-0012030887-0012025-04-22
20889483576707Multi-Link™2052104-0082052104-0082025-04-22
20889483578671Vital Signs™22616605226166052025-04-22
20889483578695Vital Signs™22616611226166112025-04-22
20889483578701Vital Signs™22616702226167022025-04-22
20889483583361Medisorb™4270001004270001002025-04-22
20889483589929Medisorb™800313880031382025-04-22
20889483590529Medisorb™857004385700432025-04-22
20889483602833Vital Signs™M1087562M10875622025-04-22
20889483603359Vital Signs™M1154610M11546102025-04-22
20889483576554Vital Signs™2036970-0012036970-0012025-04-17
20889483602918AirLife™M1093120M10931202025-04-17
20889483602925AirLife™M1093121M10931212025-04-17
20889483602932AirLife™M1093122M10931222025-04-17
20889483602949AirLife™M1093123M10931232025-04-17
20889483603038AirLife™M1097108M10971082025-04-17
20889483603045AirLife™M1097109M10971092025-04-17
10889483583388Vital Signs™4270107004270107002025-04-14
10889483587072Vital Signs™5870402005870402002025-04-14

Other Devices Sharing Product Codes

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00884838128880Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
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00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-03-09
04538612228483FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-03-06
00884838086678Masimo Sedline ModulePhilips Medizin Systeme Böblingen GmbHMHX2026-01-15
00199874152509MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
00199874432199MedibluMEDIBLU MEDICAL LLCMHX2025-12-23
04538612916236FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916243FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916250FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612916267FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-17
04538612061905FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916281FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916304FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
04538612916403FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-12-16
00884838127074Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-11-17
00884838107809Patient Monitor 6500Philips Medizin Systeme Böblingen GmbHMHX2025-11-11
06944413838420Patient MonitorEdan Instruments, Inc.MHX2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.MHX2025-09-05
07613365004168ARGUS PB-3000Schiller AGMHX2025-08-19
07613365004359ARGUS PB-3000Schiller AGMHX2025-08-19
00816787024388Remote Control RF 2100 With PadsPARKS MEDICAL ELECTRONICS, INC.MHX2025-07-18
00690103219111CableEdwards Lifesciences LLCMHX2025-07-15
04538612916335FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2025-05-29
00884838127067Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2025-05-13
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2025-05-06
10889483574324Vital Signs™AirLife Finland OyMHX2025-03-31