Pathnet Blood Bank Transfusion (L-2300)

GUDID 05060508820000

CIRDAN IMAGING LIMITED

Blood bank information system

• Primary Device ID: 05060508820000
• NIH Device Record Key: 694a73be-2c0f-46ec-8190-ba0a2b3739be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathnet Blood Bank Transfusion (L-2300)
• Version Model Number: 4.1
• Company DUNS: 216744109
• Company Name: CIRDAN IMAGING LIMITED
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	05060508820000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK050018

FDA Product Code

• MMH: Software, Blood Bank, Stand Alone Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-27
• Device Publish Date: 2016-11-21

Devices Manufactured by CIRDAN IMAGING LIMITED

• 05060508820017 - CoreLite: 2020-04-08 X-ray specimen cabinet
• 05060508820000 - Pathnet Blood Bank Transfusion (L-2300): 2019-09-27
• 05060508820000 - Pathnet Blood Bank Transfusion (L-2300): 2019-09-27