AccessGUDID - DEVICE: eWave Electrode Patch (P00010)

GUDID

Device Identifier (DI) Information

Brand Name: eWave Electrode Patch
Version or Model: eWave Electrode Patch
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P0001
Company Name: Wearlinq, Inc.

Primary DI Number: P00010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144863125 *Terms of Use

Device Description: Adhesive Electrode Patch

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:	Yes
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?
62597	Ambulatory recorder conductive patch	An adhesive patch intended to fix a patient-worn recorder (e.g., electrocardiographic long-term ambulatory recorder) to skin electrodes during long-term electrophysiological recording/monitoring [e.g., electrocardiogram (ECG)], and to transmit the electrical signals from the electrodes to the recorder. It is an electrical conducting patch made of metal and synthetic polymer materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSH	Recorder, Magnetic Tape, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214073	000

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
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 87 Millimeter
Width: 62 Millimeter

Device Record Status

Public Device Record Key: 9a0a7265-5ced-4877-8d96-1e3003b11175
Public Version Date: April 10, 2026
Public Version Number: 1
DI Record Publish Date: April 02, 2026

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: 1-800-785-4354
Email: support@wearlinq.com

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