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.

• 06948538369173 - PAP Link: 2025-09-29PAP Link
• 06948538369173 - PAP Link: 2025-09-29 PAP Link
• 06948538363553 - /: 2025-06-17 G3 X APAP
• 06948538363560 - /: 2025-06-17 G3 X APAP
• 06948538366363 - /: 2025-06-17 G3 X BPAP 25A
• 06948538366387 - /: 2025-06-17 G3 X BPAP System
• 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