Myocardial Needle Temperature Probe

GUDID B04021232N

Myocardial Needle Temperature Probe

GENESEE BIOMEDICAL, INC.

General-purpose patient temperature probe, single-use

• Primary Device ID: B04021232N
• NIH Device Record Key: 1eb42a47-d89c-40b3-9b3f-c9f18e729c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myocardial Needle Temperature Probe
• Version Model Number: 2123
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Dimensions

• Length: 15 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B04021231 [Primary]
HIBCC	B04021232N [Package]; Contains: B04021231; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K813459

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-01

On-Brand Devices [Myocardial Needle Temperature Probe]

• B040XE24252W: Myocardial Needle Temperature Probe
• B040XE21262U: Myocardial Needle Temperature Probe
• B040XE21252T: Myocardial Needle Temperature Probe
• B04024262T: Myocardial Needle Temperature Probe
• B04024242R: Myocardial Needle Temperature Probe
• B04024232Q: Myocardial Needle Temperature Probe
• B04021242O: Myocardial Needle Temperature Probe
• B04021232N: Myocardial Needle Temperature Probe