AccessGUDID - DEVICE: Bio Protech (00817120020579)

GUDID

Device Identifier (DI) Information

Brand Name: Bio Protech
Version or Model: MaxIF 1k Unit
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIO PROTECH USA, INC.

Primary DI Number: 00817120020579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789127011 *Terms of Use

Device Description: MaxIF 1k Unit- Interferential Analog Unit

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36737	Interferential electrical stimulation system	An electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIH	Interferential Current Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100246	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e121c634-673a-454f-adbf-6f8a64c8b896
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20817120020573	4	10817120020576		In Commercial Distribution	Master Case
10817120020576	5	00817120020579		In Commercial Distribution	Inner Box

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

Customer Contact

[?]

Phone: 714-730-9950
Email: bioprotechusa@gmail.com

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

FDA TOOLS & RESOURCES