BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder 368655

GUDID 50382903686556

Wingset SLBCS 23x.75 7 Preattached

BECTON, DICKINSON AND COMPANY

Blood collection set, invasive

• Primary Device ID: 50382903686556
• NIH Device Record Key: 613d2fc6-9a0e-4f74-a55b-d4b40034db42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder
• Version Model Number: 368655
• Catalog Number: 368655
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 25
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903686551 [Unit of Use]
GS1	30382903686552 [Primary]
GS1	50382903686556 [Package]; Contains: 30382903686552; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980414

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

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: 2024-04-16
• Device Publish Date: 2024-04-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

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• 50382903667029 - BD Vacutainer® No Additive (Z) Tubes: 2025-01-31 TUBE PLN PLH 13X75 2.5 PLBL
• 50382903247054 - BD Insulin Syringe: 2024-12-16 U-100 Insulin Syringe, 1.0mL, 27G x 12.7mm
• 00382902900207 - BD Sputum Collection System: 2024-11-27 BD Sputum Collection System, Case of 72 units
• 30382902461006 - BD Kiestra™ Isolate Suspension Cuvette Array: 2024-11-27 BD Kiestra™ Isolate Suspension Cuvette Array
• 50382903032780 - Eclipse Needle: 2024-11-21 NEEDLE ECLIPSE 23X1-1/2 RB TW BNS
• 60382904454755 - BD BACTEC™ 9240: 2024-11-12 BD BACTEC™ 9240
• 60382904455707 - BD BACTEC™ 9120: 2024-11-12 BD BACTEC™ 9120