Pulse Scientific Inc.

GUDID 00628055726029

Pulse Scientific Inc

C-reactive protein (CRP) IVD, reagent

• Primary Device ID: 00628055726029
• NIH Device Record Key: 3cdc7c60-b95a-4b7d-a9f2-ad47a101b01f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Scientific Inc.
• Version Model Number: 10103
• Company DUNS: 249257254
• Company Name: Pulse Scientific Inc
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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	00628055726029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923768

FDA Product Code

• DCK: C-Reactive Protein, Antigen, Antiserum, And Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-04

On-Brand Devices [Pulse Scientific Inc.]

• 00628055726036: 10503
• 00628055726029: 10103
• 00628055726012: 10605
• 00628055726005: 10603