Salter ETCo2/O2 Cannula

GUDID 10889483610961

Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 13' ETCO2 line

SALTER LABS

Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 10889483610961
• NIH Device Record Key: 389e920c-8dcb-4698-9647-413464c919ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salter ETCo2/O2 Cannula
• Version Model Number: 4MSF1SOFT-7-13
• 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: true
• Serial Number: false
• 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	10889483610961 [Primary]
GS1	30889483610965 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151421

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2024-04-08
• Device Publish Date: 2024-03-31

On-Brand Devices [Salter ETCo2/O2 Cannula]

• 30889483611146: Pediatric. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line
• 30889483611023: Pediatric. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line, for pr
• 30889483611016: Adult. O2/ETCO2 Filtered Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line, for prolonged d
• 30889483611009: Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line, for prolon
• 30889483610996: Adult. O2/ETCO2 Filtered Nasal Divided Soft Cannula, 7' O2 line, 13' ETCO2 line
• 30889483610989: 4MSF3SOFT-7-6
• 10889483610961: Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 13' ETCO2 line
• 30889483610958: Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line