Comfort Soft Plus

GUDID 20889483230272

Comfort Soft plus Oral/Nasal Divided Adult Cannula

SALTER LABS

Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 20889483230272
• NIH Device Record Key: 67703581-2dd2-47bb-8601-82314a310082
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Soft Plus
• Version Model Number: 0913
• 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	10889483230275 [Primary]
GS1	20889483230272 [Package]; Contains: 10889483230275; 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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Comfort Soft Plus]

• 20889483234072: Comfort Soft Plus Oral/Nasal Divided Adult Cannula
• 20889483234003: Comfort Soft Plus Adult Cannula
• 20889483233990: Comfort Soft Plus Adult Cannula
• 20889483231200: Comfort Soft Plus Adult Cannula
• 20889483230890: Comfort Soft Plus Oral/Nasal Divided Adult Cannula, w/ 2” CO2 pigtail
• 20889483230883: Comfort Soft Plus Oral/Nasal Divided Adult Cannula
• 20889483230319: Comfort Soft Plus ETCo2/O2 Divided Pediatric Cannula
• 20889483230302: Comfort Soft Plus ETCo2/O2 Divided Adult Cannula
• 20889483230296: Comfort Soft Plus Oral/Nasal Divided Adult Cannula
• 20889483230272: Comfort Soft plus Oral/Nasal Divided Adult Cannula
• 20889483230067: Comfort Soft Plus Infant Cannula
• 10889483230053: Comfort Soft Plus Neonatal Cannula
• 10889483229040: Comfort Soft Plus Adult Mico Cannula
• 20889483228989: Comfort Soft Plus Adult Cannula
• 20889483227760: Comfort Soft Plus Demand Adult Cannula
• 20889483227685: Comfort Soft Plus Oral/Nasal Divided Adult Cannula, Male Luer, w/ 2” Female pigtail adapter
• 10889483227626: Comfort Soft Plus Neonatal Cannula
• 20889483227319: Comfort Soft Plus High Flow Adult Cannula
• 20889483227197: Comfort Soft Plus Adult Cannula
• 20889483222864: Comfort Soft Plus ETCo2/O2 Divided Adult Cannula
• 20889483222635: Comfort Soft Plus ETCo2/O2 Divided Adult Cannula
• 20889483222437: Comfort Soft Plus ETCO2 Divided Adult Cannula