AccessGUDID - DEVICE: BrainScope One International Charging Kit (00852745007093)

GUDID

Device Identifier (DI) Information

Brand Name: BrainScope One International Charging Kit
Version or Model: 99-1403-028
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Brainscope Company, Inc.

Primary DI Number: 00852745007093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 805670416 *Terms of Use

Device Description: No description.

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?
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLU	Normalizing Quantitative Electroencephalograph Software
PKQ	Computerized Cognitive Assessment Aid
PIW	Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161068	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: 7f9cf6d6-125a-4db5-887d-a238e56fbbca
Public Version Date: September 27, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2018