Q-Syte 385103

GUDID 30382903851035

Luer Access Split Septum

BECTON, DICKINSON AND COMPANY

Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector Negative-pressure intravenous line needleless valve-connector

• Primary Device ID: 30382903851035
• NIH Device Record Key: 1e4fda51-c6e7-4a27-9cb8-b5a18db17759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Syte
• Version Model Number: 385103
• Catalog Number: 385103
• 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
• 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

• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch
• Length: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903851034 [Primary]
GS1	30382903851035 [Package]; Contains: 00382903851034; Package: Box [50 Units]; In Commercial Distribution
GS1	50382903851039 [Package]; Contains: 00382903851034; Package: Case [200 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: 2023-08-04
• Device Publish Date: 2023-07-27

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