Q-Syte 385106

GUDID 50382903851060

Vial Access Adapter

BECTON, DICKINSON AND COMPANY

Fluid transfer set, general-purpose

• Primary Device ID: 50382903851060
• NIH Device Record Key: 903ddd57-a0eb-4f50-828d-9c8b56e2f2f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Syte
• Version Model Number: 385106
• Catalog Number: 385106
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• 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(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com

Device Dimensions

• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter
• Total Volume: 0.16 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903851065 [Primary]
GS1	30382903851066 [Package]; Contains: 00382903851065; Package: Box [25 Units]; In Commercial Distribution
GS1	50382903851060 [Package]; Contains: 00382903851065; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013621

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-18
• Device Publish Date: 2023-08-10

On-Brand Devices [Q-Syte]

• 50382903851619: Bi-Extension Set 15 cm (6 IN)
• 50382903851589: Tri-Extension Set 15 cm (6 IN)
• 50382903851572: Bi-Extension Set 15 cm (6 IN)
• 50382903851565: Tri-Extension Set 15 cm (6 IN)
• 50382903851558: Bi-Extension Set 15 cm (6 in)
• 50382903851527: Extension Set 15 cm (6 IN)
• 50382903851510: Extension Set 15 cm (6 IN)
• 50382903851503: Extension Set Rightbore15 cm (6 IN)
• 30382903851059: Extension Set 15 cm (6 IN)
• 50382903851046: Extension Set 15 cm (6 IN)
• 30382903851035: Luer Access Split Septum
• 50382903851060: Vial Access Adapter