AccessGUDID - DEVICE: UbiqVue (B353UA2550C1)

GUDID

Device Identifier (DI) Information

Brand Name: UbiqVue
Version or Model: UA2550-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lifesignals, Inc.

Primary DI Number: B353UA2550C1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 798830720 *Terms of Use

Device Description: Active Monitoring Portal

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65832	Wireless patient monitor/sensor reporting software, professional-only	A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring.	Active	false
65831	Wearable multiple vital physiological parameter monitor	A portable assembly of electrically-powered devices intended to be worn by an ambulatory patient in a healthcare setting for intermittent assessment or continuous monitoring of several vital physiologic parameters [e.g., electrocardiogram (ECG), respiration rate, haemoglobin oxygen saturation (SpO2)] while allowing freedom of movement (e.g., in step-down care areas). It includes processing hardware to be used with dedicated software (that may be pre-installed); the sensors, probes, and/or electrodes are not included. It typically incorporates a monitoring screen and may allow communication with a stationary device (e.g., off-the shelf computer).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
FLL	Thermometer, Electronic, Clinical
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69428d8a-3f74-4324-97a6-338b9c4694d5
Public Version Date: December 02, 2024
Public Version Number: 2
DI Record Publish Date: May 15, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 510.770.6412
Email: saravanan@lifesignals.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES