Bjingles BJL-995

GUDID 00861910000340

Infrared Thermometer

NK AMERICAN WAY, LLC

Infrared patient thermometer, skin

• Primary Device ID: 00861910000340
• NIH Device Record Key: 5758f220-be97-4ef4-9e63-ffc4c164bc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bjingles
• Version Model Number: BJL-995
• Catalog Number: BJL-995
• 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	00861910000340 [Primary]
GS1	10861910000347 [Package]; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171214

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-23

On-Brand Devices [Bjingles]

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