FDA.reportPublic FDA data

UbiqVue Multiparameter

Primary DI
B353UB25501
Brand
UbiqVue Multiparameter
Company
Lifesignals, Inc.
Model
UB2550
Device description
2A Wearable Biosensor
Published
2024-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
FLLThermometer, Electronic, Clinical
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B353UB25502PackageHIBCC25In Commercial Distribution
B353UB25503PackageHIBCC4In Commercial Distribution
B353UB25501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, single-useAn electrically-powered wearable device (e.g., skin patch) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), haematocrit] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis or for remote monitoring (e.g., of dialysis patients) by a healthcare professional. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius
Special Storage Condition, Specify00For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
510.770.6412saravanan@lifesignals.com

Regulatory Flags#

DUNS number
798830720
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B353UB25511UbiqVue MultiparameterUB25512026-07-20
B353LP12531LifeSignalsLP1253LP1253_US2021-01-28
B353UB12511UbiqVue HolterUB12512025-04-22
B353UB22511UbiqVue HolterUB22512025-04-22
B353UA2251C1UbiqVueUA2251-C2025-04-22
B353UA2251DA1UbiqVueUA2251-DA2025-04-22
B353UA2251R1UbiqVueUA2251-R2025-04-22
B353UA2251S1UbiqVueUA2251-S2025-04-22
B353UA2251SA1UbiqVueUA2251-SA2025-04-22
B353UA2251W1UbiqVueUA2251-W2025-04-22
B353LA1252C1HOLTER CONNECTLA1252C2021-11-15
B353LA1252R1HOLTER CONNECTLA1252R2021-11-15
B353CV12531CorVitalsCV1253CV1253_US2021-05-14
B353UB12512UbiqVue HolterUB12512025-04-22
B353UB22512UbiqVue HolterUB22512025-04-22
B353UB25502UbiqVue MultiparameterUB25502024-11-29
B353UA2550BG1UbiqVue UA2550-BG2024-05-15
B353UA2550C1UbiqVue UA2550-C2024-05-15
B353UA2550MR1UbiqVue UA2550-MR2024-05-15
B353UA2550RB1UbiqVue UA2550-RB2024-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00860011800613CardioTagCARDIOSENSE, INC.DRG2026-10-14
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28