Puriblood

GUDID 14719878520482

PURIBLOOD MEDICAL CO., LTD.

Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange

• Primary Device ID: 14719878520482
• NIH Device Record Key: 438a687e-a6fb-4639-b4e2-f79798f3fa9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puriblood
• Version Model Number: LRW-50-05-PS
• Company DUNS: 658873912
• Company Name: PURIBLOOD MEDICAL CO., LTD.
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878520485 [Primary]
GS1	14719878520482 [Package]; Contains: 04719878520485; Package: carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK180188

FDA Product Code

• KSR: Container, Empty, For Collection & Processing Of Blood & Blood Components

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: 2024-02-26
• Device Publish Date: 2024-02-16

On-Brand Devices [Puriblood]

• 14719878520512: LRW-50-08-PS
• 14719878520505: LRW-50-07-PS
• 14719878520499: LRW-50-06-PS
• 14719878520482: LRW-50-05-PS
• 14719878520475: LRW-50-04-PS
• 14719878520468: LRW-50-01-PS