GUDID 06948538363171

Luna II CPAP

BMC Medical Co., Ltd.

Home CPAP unit

• Primary Device ID: 06948538363171
• NIH Device Record Key: 9dffc025-c10c-4aed-bd9c-f3274b8af212
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LG2000
• 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	06948538363171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153387

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: 3
• Public Version Date: 2020-02-10
• Device Publish Date: 2018-08-31

Devices Manufactured by BMC Medical Co., Ltd.

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• 36948538368047 - Siesta 2 Nasal Mask: 2024-04-10 Siesta 2 Nasal Mask
• 36948538368054 - Siesta 2 Nasal Mask: 2024-04-10 Siesta 2 Nasal Mask
• 36948538368061 - Siesta 2 Nasal Mask: 2024-04-10 Siesta 2 Nasal Mask
• 36948538368078 - Siesta 2 Nasal Mask: 2024-04-10 Siesta 2 Nasal Mask
• 36948538368085 - Siesta 2 Full Face Mask: 2024-04-10 Siesta 2 Full Face Mask
• 36948538368092 - Siesta 2 Full Face Mask: 2024-04-10 Siesta 2 Full Face Mask
• 06948538368107 - Siesta 2 Full Face Mask: 2024-04-10 Siesta 2 Full Face Mask