BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder 368653

GUDID 50382903686532

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

BECTON, DICKINSON AND COMPANY

Venous butterfly needle/set

• Primary Device ID: 50382903686532
• NIH Device Record Key: f0ad79a1-53bf-4a39-a193-d403a3cbb235
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder
• Version Model Number: 368653
• Catalog Number: 368653
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 200
• 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

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
• 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
• 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	00382903686537 [Unit of Use]
GS1	30382903686538 [Package]; Package: Shelfpack [25 Units]; In Commercial Distribution
GS1	50382903686532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991088

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-22

On-Brand Devices [BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder]

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• 00382903686537: Wingset SLBCS 23x.75 12 Preattached
• 00382903686520: BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder
• 50382903686549: Wingset SLBCS 21x.75 7 Preattached
• 30382903686538: Wingset SLBCS 23x.75 12 Preattached
• 30382903686521: BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder