BD Q-Syte 385100

GUDID 50382903851008

Q-SYTE CLOSED LUER ACCESS DEVICE

BECTON, DICKINSON AND COMPANY

Catheter injection port

• Primary Device ID: 50382903851008
• NIH Device Record Key: fcecc5e9-b402-4539-b157-91cb5350efc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Q-Syte
• Version Model Number: 385100
• Catalog Number: 385100
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 50
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903851003 [Unit of Use]
GS1	30382903851004 [Primary]
GS1	50382903851008 [Package]; Contains: 30382903851004; Package: Case [4 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [BD Q-Syte]

• 50382903851657: Y EXT SET 20CM MACRO BORE SPIN NUT
• 50382903851640: TRI-EXT SET 15CM SMALL BORE SPIN NUT
• 50382903851633: BI-EXT SET 15CM SMALL BORE SPIN NUT
• 50382903851626: TRI-EXT SET 15CM MACRO BORE SPIN NUT
• 50382903851084: Q-SYTE VIAL ACCESS ADAPTER
• 50382903851022: Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE
• 50382903851015: Q-SYTE EXT SET, LUER-LOK 6 IN STD BORE
• 50382903851008: Q-SYTE CLOSED LUER ACCESS DEVICE
• 00382903851652: Y-Extension Set 20 cm (8 IN)
• 00382903851645: Tri Extension Set 15 cm (6IN)
• 00382903851638: Bi-Extension Set 15 cm (6 IN)
• 00382903851621: Tri-Extension Set 15 cm (6 IN)