PAP Link

GUDID 06948538369173

PAP Link

BMC Medical Co., Ltd.

Ventilator application software

• Primary Device ID: 06948538369173
• NIH Device Record Key: 1762b9e1-beb0-450a-8e17-0b638c15ea5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAP Link
• Version Model Number: PAP Link PC
• 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: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948538369173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242935

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-19

Devices Manufactured by BMC Medical Co., Ltd.

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• 16948538340179 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask
• 16948538340186 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask
• 16948538340193 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask
• 16948538340209 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask
• 16948538340216 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask
• 16948538340223 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask
• 16948538340230 - Siesta Contour Nasal Mask: 2026-02-10 Siesta Contour Nasal Mask