Bjingles BJL-755

GUDID 10861910000309

Fetal Doppler System

NK AMERICAN WAY, LLC

Foetal Doppler system

• Primary Device ID: 10861910000309
• NIH Device Record Key: 8e770ee7-d57b-4520-ae0e-a706d90a5bdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bjingles
• Version Model Number: BJL-755
• Catalog Number: BJL-755
• Company DUNS: 080342743
• Company Name: NK AMERICAN WAY, LLC
• 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: 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	00861910000302 [Primary]
GS1	10861910000309 [Package]; Contains: 00861910000302; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110124

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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: 2016-08-22

On-Brand Devices [Bjingles]

• 00861910000340: Infrared Thermometer
• 10861910000309: Fetal Doppler System
• 00860001273717: Infrared Thermometer