FifthPulse

GUDID 00810084930625

Jeg & Sons Inc.

Glucose rapid test/blood pressure system analyser, home-use

• Primary Device ID: 00810084930625
• NIH Device Record Key: 15319c9d-936f-4925-a24c-e16a2fc58d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FifthPulse
• Version Model Number: FP100-TS
• Company DUNS: 789973646
• Company Name: Jeg & Sons Inc.
• Device Count: 100
• 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	00810084930625 [Unit of Use]
GS1	00850026094305 [Primary]
GS1	00850028714492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153561

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [FifthPulse]

• 00850028714751: FP810-WM
• 00850028714614: FP607-GK
• 00810084930618: FP100-L
• 00810084930625: FP100-TS
• 00850026094299: FP607-G
• 00810084938379: Stretch Gauze Bandage
• 00810084938362: Sterile Abdominal Wound Dressing Pad