raiing iThermonitor

GUDID 06957324200286

Raiing Medical Company

Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 06957324200286
• NIH Device Record Key: 8ab04b4e-1604-4ba3-bc44-33f8f70fc1cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: raiing iThermonitor
• Version Model Number: WT701
• Company DUNS: 421278181
• Company Name: Raiing Medical Company
• 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	06957324200286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132761

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

[06957324200286]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-11-01

On-Brand Devices [raiing iThermonitor]

• 06957324200156: WT701
• 06957324200286: WT701