BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364391

GUDID 00382903643912

SYR ABG PRESET 3(1.6) LL 23X1 ECLIPSE CE

Becton, Dickinson U.K. Limited

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• Primary Device ID: 00382903643912
• NIH Device Record Key: 3a16162b-c4b6-48e0-a6b3-71973ae6d871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Preset™ Eclipse™ Arterial Blood Collection Syringe
• Version Model Number: 364391
• Catalog Number: 364391
• Company DUNS: 225931062
• Company Name: Becton, Dickinson U.K. Limited
• Device Count: 100
• 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: 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	00382903643912 [Unit of Use]
GS1	50382903643917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202446

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: 2024-04-10
• Device Publish Date: 2024-04-02

On-Brand Devices [BD Preset™ Eclipse™ Arterial Blood Collection Syringe]

• 00382903643936: SYR ABG PRESET 3(1.6) LL 25X5/8 ECLIPSE
• 00382903643912: SYR ABG PRESET 3(1.6) LL 23X1 ECLIPSE CE
• 00382903643905: SYR ABG PRESET 3(1.6) LL 22X1 ECLIPSE CE
• 00382903643899: SYR ABG PRESET 3(1.6) 22X1.25 ECLIPSE CE