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

• 30889483236325 - Iradimed Adult Capnography Cannula: 2025-08-12 Iradimed, Sampling Adult Capnography Cannula, Male Luer Style, 7' CO2, No O2
• 30889483236332 - Iradimed Infant Capnography Cannula: 2025-08-12 Iradimed, Sampling Infant Capnography Cannula, Male Luer Style, 7' CO2, No O2
• 30889483236349 - Iradimed Pediatric Capnography Cannula: 2025-08-12 Iradimed, Sampling Pediatric Capnography Cannula, Male Luer Style, 7' CO2, No O2
• 30889483236356 - Iradimed: 2025-08-12 Iradimed Adult Oral / Nasal Canula
• 30889483236363 - Iradimed: 2025-08-12 Iradimed Pediatric Oral / Nasal Cannula
• 30889483236370 - Iradimed: 2025-08-12 Iradimed Divided Adult Nasal Canula
• 30889483236387 - Iradimed: 2025-08-12 Iradimed Divided Pediatric Nasal Canula
• 30889483236318 - Iradimed Sample Line Extension: 2025-08-12 Iradimed Sample Line Extension