Temp Probe

GUDID 10803622140225

LIVANOVA USA, INC.

General-purpose patient temperature probe, reusable

• Primary Device ID: 10803622140225
• NIH Device Record Key: a3dc793a-6c09-4d20-a7f6-6cdd5e94a99c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temp Probe
• Version Model Number: Temp Probe
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803622140228 [Primary]
GS1	10803622140225 [Package]; Contains: 00803622140228; Package: CASE [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962070

FDA Product Code

• FLL: Thermometer, electronic, clinical

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: 2018-08-15
• Device Publish Date: 2018-05-30

On-Brand Devices [Temp Probe]

• 10803622140225: Temp Probe
• 00803622133145: Temp Probe