BD Preset™ Arterial Blood Collection Syringe 364316

GUDID 00382903643165

SYR ABG PRESET 3(1.6) LL CE

Becton, Dickinson U.K. Limited

Blood gas syringe IVD, lithium heparin

• Primary Device ID: 00382903643165
• NIH Device Record Key: c5f235af-fec2-45de-9e0c-7e9302656c0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Preset™ Arterial Blood Collection Syringe
• Version Model Number: 364316
• Catalog Number: 364316
• 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
• 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	00382903643165 [Unit of Use]
GS1	50382903643160 [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: 2024-04-02
• Device Publish Date: 2024-03-25

Devices Manufactured by Becton, Dickinson U.K. Limited

• 00382903660162 - BD Seditainer™ Stand: 2024-04-26 ESR SEDITAINER TUBE STAND FOR 10 TUBES
• 50382903688864 - BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes: 2024-04-16 TUBE LIHEP PLH 13X100 6.0 PLBLCE GN
• 50382903684941 - BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes: 2024-04-12 TUBE LIHEP PLH 13X75 2.0 PLCE GN
• 50382903685016 - BD Vacutainer® Z (No Additive) Plus Urine Tube: 2024-04-12 TUBE URIN PLH 13X100 6.0 UA TAN
• 50382903688840 - BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes: 2024-04-12 TUBE LIHEP PLH 13X75 4.0 PLBLCE GN
• 00382903643783 - BD A-Line™ Arterial Blood Collection Syringe: 2024-04-10 SYR ABG ALINE 3(1) LL CE
• 00382903643899 - BD Preset™ Eclipse™ Arterial Blood Collection Syringe: 2024-04-10 SYR ABG PRESET 3(1.6) 22X1.25 ECLIPSE CE
• 00382903643905 - BD Preset™ Eclipse™ Arterial Blood Collection Syringe: 2024-04-10 SYR ABG PRESET 3(1.6) LL 22X1 ECLIPSE CE