Resmed Sleep Apnealink Cannula

GUDID 30889483610569

Nasal Cannula PG/PSG

SALTER LABS

Respiratory apnoea monitoring system

• Primary Device ID: 30889483610569
• NIH Device Record Key: 20309039-960b-43dd-bebb-6d2c4b5cd9f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resmed Sleep Apnealink Cannula
• Version Model Number: 70710316
• Company DUNS: 022721133
• Company Name: SALTER LABS
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483610565 [Primary]
GS1	30889483610569 [Package]; Contains: 10889483610565; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151874

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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: 2025-07-21
• Device Publish Date: 2025-07-11

Devices Manufactured by SALTER LABS

• 30889483610569 - Resmed Sleep Apnealink Cannula: 2025-07-21Nasal Cannula PG/PSG
• 30889483610569 - Resmed Sleep Apnealink Cannula: 2025-07-21 Nasal Cannula PG/PSG
• 20889483569990 - O2 Cannula: 2025-01-08 Nasal Oxygen Cannula Curved, Flared Tip with 14 foot (4.3m) Crush-Resistant Tubing, Over-the-Ear Style and U/Connect-It Adapter
• 20889483570019 - O2 Cannula: 2025-01-08 Nasal Oxygen Cannula Curved, Flared Tip with 21 foot (6.4m) Crush-Resistant Tubing, Over-the-Ear Style and U/Connect-It Adapter
• 20889483570040 - O2 Cannula: 2025-01-08 Nasal Oxygen Cannula Curved, Nonflared Tip with 14' (4.3m) Crush-Resistant Tubing, Over-the-Ear Style, and U/Connect-It Adapter
• 20889483570156 - O2 Cannula: 2025-01-08 Nasal Oxygen Cannula Curved, Flared Tip with 7 foot (2.1m) Crush-Resistant Tubing and U/Connect-It Adapter, Over-the-Ear Style
• 20889483571375 - O2 Cannula: 2025-01-08 Adult Cushion Nasal Cannula 25 foot (7.6 m) Crush Resistant Supply Tube and U/Connect-It Adapter
• 20889483571504 - O2 Cannula: 2025-01-08 Pediatric Cushion Nasal Cannula With 7 foot (2.1 m) Crush-Resistant Supply Tube and U/Connect-It Adapter
• 20889483605827 - O2 Cannula: 2025-01-08 Pediatric Cushion Nasal Cannula With 7 foot (2.1 m) Crush-Resistant Oxygen Tubing and U/Connect-It Adapter