AccessGUDID - DEVICE: UbiqVue (B353UA2550MR1)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: B353UA2550MR1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 798830720 *Terms of Use

Device Description: Multi Patient Relay Software

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?
64902	Physiological measuring device wireless data capture/transfer unit	A mobile electronic device/device assembly designed to be used by a healthcare professional (e.g., nurse, caregiver) to capture patient physiological parameters from wireless patient measuring devices (e.g., wireless pulse oximeter, wireless thermometer) during routine patient checks (e.g., as part of nursing rounds) and wirelessly send the information to the electronic health record. It is intended to capture and transfer patient identification and time/date with the physiological data; it will typically in addition allow for manual entry of data. It typically includes a display monitor, wireless receivers, and barcode reader.	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: e8410b14-ceb6-44e8-b149-c3b459266e6e
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

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