Apollo

GUDID 00852753008891

Apollo portable laser system

PIVOTAL HEALTH SOLUTIONS, INC.

Musculoskeletal/physical therapy laser, home-use

• Primary Device ID: 00852753008891
• NIH Device Record Key: feafae6a-01b7-4123-9bb9-0180759f3aa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo
• Version Model Number: Portable, AP2-PT
• Company DUNS: 826316098
• Company Name: PIVOTAL HEALTH SOLUTIONS, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852753008891 [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: 2
• Public Version Date: 2019-01-08
• Device Publish Date: 2018-10-16

On-Brand Devices [Apollo]

• 00852753008969: Apollo laser handheld
• 00852753008891: Apollo portable laser system
• 00852753008884: Desktop laser