AccessGUDID - DEVICE: OPTIMIZER® (00810003380029)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIMIZER®
Version or Model: Mini Charger System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-F202-3-US
Company Name: Impulse Dynamics (usa) Inc.

Primary DI Number: 00810003380029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878519342 *Terms of Use

Device Description: OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wand) (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Carrying Case

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?
33658	Implant battery charger	An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFV	Implantable Pulse Generator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180036	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
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 81863a31-61b8-4c35-8ae8-302fc8e5ab8b
Public Version Date: December 24, 2020
Public Version Number: 2
DI Record Publish Date: April 12, 2019