Reusable Temperature Probe

GUDID 06970706366547

Philips Compatible,Adult skin, 3.0M

Orantech Inc.

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• Primary Device ID: 06970706366547
• NIH Device Record Key: 2bf19255-afaf-4b80-8480-98a2c1882e97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Temperature Probe
• Version Model Number: TS-PH-AS30
• Company DUNS: 544423370
• Company Name: Orantech 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970706366547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173194

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: 1
• Public Version Date: 2021-01-01
• Device Publish Date: 2020-12-24

On-Brand Devices [Reusable Temperature Probe]

• 06970706366547: Philips Compatible,Adult skin, 3.0M
• 06970706366691: Philips Compatible,Adult rectum, 3.0M
• 06970706366653: YSI400 Compatible,Adult rectum, 3.0M
• 06970706366509: YSI400 Compatible,Adult skin, 3.0M