Redi-Temp® 8001-B

GUDID B2398001B1

Liquid crystal temperature monitor strip, individually wrapped, dispenser box

TRADEMARK MEDICAL, L.L.C.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: B2398001B1
• NIH Device Record Key: b8f6c934-8ff7-4d29-9398-1ec9a2650128
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Redi-Temp®
• Version Model Number: 8001-B
• Catalog Number: 8001-B
• Company DUNS: 024113805
• Company Name: TRADEMARK MEDICAL, L.L.C.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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
HIBCC	B2398001B0 [Unit of Use]
HIBCC	B2398001B1 [Primary]

FDA Product Code

• KPD: Strip, Temperature, Forehead, Liquid Crystal

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: 2020-02-24
• Device Publish Date: 2016-09-23

On-Brand Devices [Redi-Temp®]

• B2398001DB1: Liquid crystal temperature monitor strip, dispenser box
• B2398001B1: Liquid crystal temperature monitor strip, individually wrapped, dispenser box
• B2395010HB1: Liquid crystal temperature monitor strip (oval), individually wrapped, dispenser box