THERA Plus

GUDID 00049696299923

"THERA DIGITAL THERMOMETER FLEXIBLE 1 CT "

FOURSTAR GROUP INC.

Intermittent electronic patient thermometer

• Primary Device ID: 00049696299923
• NIH Device Record Key: 54b9b28a-50d4-4b7f-809b-73f26f1bb021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERA Plus
• Version Model Number: 11012340MB
• Company DUNS: 656091279
• Company Name: FOURSTAR GROUP 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00049696299923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102718

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: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [THERA Plus]

• 00049696299923: "THERA DIGITAL THERMOMETER FLEXIBLE 1 CT "
• 00049696507806: TP THERAPY ICE BAG
• 00049696507790: TP HEAT PATCH AIR ACTIVATED 1CT
• 00049696187886: WOMEN'S UNDERWEAR 10CT_L-XL
• 00049696187879: MEN'S UNDERWEAR 10CT_L-XL
• 00049696187206: MEN'S UNDERWEAR 10CT_S-M
• 00049696187183: WOMEN'S UNDERWEAR 10CT_S-M
• 00049696186797: Lancing Device 1CT
• 00049696186773: Lancets 200CT
• 00049696895965: ADVANCED HEALING BLISTER HEEL BANDAGES
• 00049696895927: ADVANCED HEALING GEL HEEL BANDAGES