FifthPulse

GUDID 00850026094299

Jeg & Sons Inc.

Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00850026094299
• NIH Device Record Key: ccb7b7e0-0b9b-4c74-a254-51658d53d3f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FifthPulse
• Version Model Number: FP607-G
• Company DUNS: 789973646
• Company Name: Jeg & Sons 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: true
• 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	00850026094299 [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