CIRCA Temperature Standard

Basic Information

• Brand Name: CIRCA Temperature Standard
• Primary DI: 00851498007176
• Version / Model: CS-104
• Company Name: CIRCA SCIENTIFIC, LLC
• Labeler DUNS: 963223222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: f170ddc0-605c-4f7e-a216-e29686f375a1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63129	Electrical-only medical device connection cable tester	A non-powered device intended to be used to test the electrical continuity of an electrical-only medical device connection cable, which connects two medical devices (e.g., transducer and monitor). The tester is attached to one end of the cable to modulate the signal created, and then displayed/recorded, by one of the devices. It is intended to be used by a healthcare provider in a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851498007176	GS1

Premarket Submissions

Submission Number	Supplement Number
K222311	000