UbiqVue Multiparameter

Basic Information

• Brand Name: UbiqVue Multiparameter
• Primary DI: B353UB25501
• Version / Model: UB2550
• Company Name: Lifesignals, Inc.
• Labeler DUNS: 798830720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-29
• Public Version: 1
• Public Version Date: 2024-12-09
• Public Version Status: New
• Public Device Record Key: 0cb76706-46eb-4526-bc1e-a8c5e12fbaff

Device Description

2A Wearable Biosensor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66389	Wearable multiple physiological parameter recorder, single-use	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B353UB25502	HIBCC	Small Box	25	In Commercial Distribution
Primary	B353UB25501	HIBCC
Package	B353UB25503	HIBCC	Big Box	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius