CapnuVue 4737TG-7-0

GUDID 10607411971355

CapnoVue M1 Mask (Adult). With thread grip. Single patient use.

SALTER LABS

Carbon-dioxide-sampling nasal oxygen cannula Carbon-dioxide-sampling nasal oxygen cannula 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: 10607411971355
• NIH Device Record Key: ae8c5522-12f9-4e28-b8f7-ef9ab147099b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapnuVue
• Version Model Number: 4737TG-7-0
• Catalog Number: 4737TG-7-0
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *-20 C to 50 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411971358 [Primary]
GS1	10607411971355 [Package]; Contains: 00607411971358; Package: [50 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: 2020-02-04
• Device Publish Date: 2020-01-27

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