Vital Signs™ 8090C

GUDID 70190752147913

Tracheal Tube Oral/Nasal

Sunmed Group Holdings, LLC

Basic endotracheal tube, single-use

• Primary Device ID: 70190752147913
• NIH Device Record Key: c84f1e53-f5fe-49dd-bee1-96c3d89b191b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs™
• Version Model Number: 8090C
• Catalog Number: 8090C
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, LLC
• 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

Customer Support Contacts

• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752147911 [Primary]
GS1	20190752147918 [Package]; Contains: 50190752147919; Package: Box [40 Units]; In Commercial Distribution
GS1	50190752147919 [Package]; Contains: 10190752147911; Package: Case [160 Units]; In Commercial Distribution
GS1	70190752147913 [Package]; Contains: 20190752147918; Package: Pack [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042683

FDA Product Code

• BTR: Tube, tracheal (w/wo connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-11
• Device Publish Date: 2021-04-09

On-Brand Devices [Vital Signs™]

• 50190752147933: Tracheal Tube Oral/Nasal
• 20190752147925: Tracheal Tube Oral/Nasal
• 70190752147913: Tracheal Tube Oral/Nasal
• 20190752147802: Tracheal Tube Oral/Nasal
• 50190752147780: Tracheal Tube Oral/Nasal
• 50190752147773: Tracheal Tube Oral/Nasal
• 20190752147765: Tracheal Tube Oral/Nasal
• 20190752147758: Tracheal Tube Oral/Nasal
• 50190752147087: Vital Signs™ Toddler Face Mask
• 50190752146622: Vital Signs™ Child/Small Adult Face Mask
• 50190752146615: Vital Signs™ Child/Small Adult Face Mask
• 50190752146592: Vital Signs™ Toddler Face Mask
• 50190752118971: Vital Signs™ Adult Anesthesia Breathing Circuit
• 50190752118742: Vital Signs™ Jackson-Rees Circuits
• 50190752118643: Vital Signs™ Jackson-Rees Circuits
• 30889483592124: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483592384: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483600256: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483600218: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483600065: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483600010: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483599956: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483598195: Vital Signs™ Pediatric Anesthesia Breathing Circuit
• 30889483596573: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483596566: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483596214: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594838: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594807: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594746: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594562: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594326: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483594296: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483593640: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483593459: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483593305: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483593190: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483592797: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483592766: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483592735: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483592643: Vital Signs™ Adult Anesthesia Breathing Circuit
• 10889483592458: Adult Anesthesia Breathing Circuit
• 30889483600034: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483596252: Vital Signs™ Adult Anesthesia Breathing Circuit
• 30889483596221: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483595774: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483595705: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483595040: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594661: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594623: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
• 30889483594586: Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit