PC600 Digital Thermometer - White

Basic Information

• Brand Name: PC600 Digital Thermometer - White
• Primary DI: 00030028000041
• Version / Model: PC600
• Catalog Number: PC600
• Company Name: Broder Bros., Co.
• Labeler DUNS: 005381652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 14c2a23f-278e-49b4-9670-b860db3de461

Device Description

PC600 Digital Thermometer - White • ABS Plastic thermometer with 1 button cell battery (AG3), replaceable. • Each thermometer comes in 2-piece plastic storage case. Imprint on case only. • Power/Technology: Range 90.0 108.0 F. Accuracy - 0.3 F Less than 95.0 F, 0.2 F 95.0 F to 102.0 F, 0.3 F Greater than 102.0 F. Measures 77.0 F at standard room temperature. • Refer to instructions (included) for cleaning. • Features On/Off switch and 3 1/2 digit LCD display. • For oral and under-arm use only. • Takes approx. 10 seconds to read temperature, at which time device emits beeping sound. Temperature shows on display 30-60 seconds after sound goes off.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
14035	Intermittent electronic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20030028000045	GS1	Case	300	In Commercial Distribution
Package	10030028000048	GS1	Inner Box	10	In Commercial Distribution
Primary	00030028000041	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]