AccessGUDID - DEVICE: ActiPatch (00851329005340)

GUDID

Device Identifier (DI) Information

Brand Name: ActiPatch
Version or Model: 088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720-4
Company Name: Bioelectronics Corporation

Primary DI Number: 00851329005340
Issuing Agency: GS1
Commercial Distribution End Date: July 23, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 101591571 *Terms of Use

Device Description: Back, Knee, Muscle & Joint Advanced Long-Lasting Relief.

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):	No
Over the Counter (OTC):	Yes
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?
35169	Hand-held deep-tissue electromagnetic stimulator	A battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQY	Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

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 -13 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e8d8ad6-ed54-4649-9768-3d7b9ac17b72
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: July 23, 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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 301-874-4890
Email: brice@bielcorp.com

Phone: 301-874-4890
Email: rcarusone@bielcorp.com

Phone: 3018744890
Email: zatiq@bielcorp.com

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

FDA TOOLS & RESOURCES