GUDID 06948538362242

Siesta Full Face Mask Replacement Headgear

BMC Medical Co., Ltd.

CPAP/BPAP face mask, reusable

• Primary Device ID: 06948538362242
• NIH Device Record Key: cb6e3b40-2647-4487-ba46-b0cc6bc663d1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NA
• 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: true
• Serial Number: false
• 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	06948538362242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131901

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: 2020-02-10
• Device Publish Date: 2019-06-21

Devices Manufactured by BMC Medical Co., Ltd.

• 36948538368030 - Siesta 2 Nasal Mask: 2024-04-10 Siesta 2 Nasal Mask
• 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