Vital Signs™ 8035UC

GUDID 20190752147765

Tracheal Tube Oral/Nasal

Sunmed Group Holdings, LLC

Basic endotracheal tube, single-use

• Primary Device ID: 20190752147765
• NIH Device Record Key: 7368bf9b-ef52-4182-bc2a-1f51d505735e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs™
• Version Model Number: 8035UC
• Catalog Number: 8035UC
• 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

• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752147768 [Primary]
GS1	20190752147765 [Package]; Contains: 50190752147766; Package: Box [40 Units]; In Commercial Distribution
GS1	50190752147766 [Package]; Contains: 10190752147768; Package: Case [160 Units]; In Commercial Distribution
GS1	70190752147760 [Package]; 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

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• 50190752147780: Tracheal Tube Oral/Nasal
• 50190752147773: Tracheal Tube Oral/Nasal
• 20190752147765: Tracheal Tube Oral/Nasal
• 20190752147758: Tracheal Tube Oral/Nasal
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• 50190752146615: Vital Signs™ Child/Small Adult Face Mask
• 50190752146592: Vital Signs™ Toddler Face Mask
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