Luna®

GUDID 06948538363003

Luna® Auto CPAP System

BMC Medical Co., Ltd.

Home CPAP unit

• Primary Device ID: 06948538363003
• NIH Device Record Key: 68e48a3b-1b3c-45e6-9150-05dd48c543ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luna®
• Version Model Number: E-20A-H-O
• Company DUNS: 526010310
• Company Name: BMC Medical Co., Ltd.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-863-226-6285
• Email: cpewitt@3Bproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948538363003 [Primary]

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2018-03-29
• Device Publish Date: 2016-05-19

On-Brand Devices [Luna®]

• 06948538363126: Luna® CPAP System with Integrated Heated Humidifier
• 06948538363119: Luna® Auto CPAP System with Integrated Heated Humidifier
• 06948538363102: Luna® Auto CPAP System with Integrated Heated Humidifier
• 06948538363027: Luna® CPAP System
• 06948538363010: Luna® Auto CPAP System
• 06948538363003: Luna® Auto CPAP System
• 16948538362041: Luna® Integrated Heated Humidifier
• 06948538365731: Luna® G3 BPAP System
• 06948538365724: Luna® G3 BPAP System
• 06948538365717: Luna® G3 BPAP System
• 06948538365700: Luna® G3 BPAP System
• 06948538365694: Luna® G3 BPAP System
• 06948538365687: Luna® G3 BPAP System
• 06948538365649: Luna® G3 BPAP 25A
• 06948538365632: Luna® G3 BPAP 25A
• 06948538365625: Luna® G3 CPAP
• 06948538363331: Luna® G3 APAP
• 06948538363324: Luna® G3 CPAP
• 06948538365618: Luna® G3 APAP
• 06948538365601: Luna® G3 BPAP 25A
• 06948538363348: Luna® G3 CPAP
• 06948538363317: Luna® G3 APAP
• 06948538363300: Luna® II CPAP
• 06948538363294: Luna® II Auto CPAP
• 06948538363287: Luna® II CPAP
• 06948538363270: Luna® II Auto CPAP