AccessGUDID - DEVICE: Cala Trio (00851749007139)

GUDID

Device Identifier (DI) Information

Brand Name: Cala Trio
Version or Model: TLA-3160
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CALA HEALTH, INC.

Primary DI Number: 00851749007139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078877556 *Terms of Use

Device Description: Band M-R

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
64948	Tremor-suppression transcutaneous electrical stimulation wristband	An electrically-powered device designed to be worn on the wrist of an adult patient with hand tremors [e.g., due to Parkinson’s disease, essential tremor (ET)] to: 1) collect motion data (e.g., tremor frequency); and 2) apply patient-specific electrical stimuli to the median and/or radial nerve(s) through the skin (transcutaneously) to help suppress or cancel the tremors. It is a wristwatch-like device that includes a motion sensor, pulse generator and electrodes; the technology may be referred to as transcutaneous afferent patterned stimulation (TAPS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBC	External Upper Limb Tremor Stimulator

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
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 101 KiloPascal
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 164 Millimeter

Device Record Status

Public Device Record Key: 5e1d1273-6133-4add-b58f-b75bdd2fada2
Public Version Date: June 19, 2023
Public Version Number: 2
DI Record Publish Date: June 30, 2020

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-699-1009
Email: CustomerSuccess@CalaTrio.com

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