BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml 366065

GUDID 50382903660655

BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml

Becton, Dickinson U.K. Limited

Evacuated blood collection tube IVD, sodium citrate Evacuated blood collection tube IVD, sodium citrate Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD

• Primary Device ID: 50382903660655
• NIH Device Record Key: e95db095-4653-472b-a1c4-2845d953a5d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml
• Version Model Number: 366065
• Catalog Number: 366065
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903660650 [Unit of Use]
GS1	50382903660655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953994

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

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