ERGOLINE 996000101

GUDID G6199960001011

Ultraviolet tanning device

JW NORTH AMERICA, INC.

Ultraviolet tanning device

• Primary Device ID: G6199960001011
• NIH Device Record Key: ed0d838b-b278-40a5-8789-29df75361b10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERGOLINE
• Version Model Number: JK 60/80 EF
• Catalog Number: 996000101
• Company DUNS: 039280558
• Company Name: JW NORTH AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5331140620 [Previous]
HIBCC	G6199960001010 [Primary]
HIBCC	G6199960001011 [Package]; Contains: G6199960001010; Package: carton box [25 Units]; In Commercial Distribution

FDA Product Code

• LEJ: Booth, Sun Tan

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-09
• Device Publish Date: 2024-08-01

On-Brand Devices [ERGOLINE]

• G6199960001011: Ultraviolet tanning device
• G6199006125551: Ultraviolet tanning device