BD Vacutainer® 9NC 0.109M 2.7 mL 363095

GUDID 50382903630955

BD Vacutainer® 9NC 0.109M 2.7 mL

Becton, Dickinson U.K. Limited

Evacuated blood collection tube IVD, sodium citrate

• Primary Device ID: 50382903630955
• NIH Device Record Key: 982d69e2-ff19-4d07-88d4-05460729be71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® 9NC 0.109M 2.7 mL
• Version Model Number: 363095
• Catalog Number: 363095
• Company DUNS: 225931062
• Company Name: Becton, Dickinson U.K. Limited
• Device Count: 1000
• 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

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903630950 [Unit of Use]
GS1	30382903630951 [Package]; Package: Shelfpack [100 Units]; In Commercial Distribution
GS1	50382903630955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013971

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-28

Devices Manufactured by Becton, Dickinson U.K. Limited

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• 50382903688840 - BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes: 2024-04-12 TUBE LIHEP PLH 13X75 4.0 PLBLCE GN
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• 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