LUMIWAVE

GUDID 00862662000213

Lumiwave Double, 400 LED's, 2x4 Pods

BIOCARE SYSTEMS INC

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00862662000213
• NIH Device Record Key: 0576e641-aefd-4f4f-b9e1-f1f02b926bce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIWAVE
• Version Model Number: DLW2X4
• Company DUNS: 046121964
• Company Name: BIOCARE SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862662000213 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-08
• Device Publish Date: 2016-11-07

On-Brand Devices [LUMIWAVE]

• 00862662000213: Lumiwave Double, 400 LED's, 2x4 Pods
• 00862662000206: Lumiwave Single LED, 200 LED's, 1x4 Pods