TOPCARE 87-639-000

GUDID 10036800396927

60 SECOND DIGITAL THERMOMETER

Topco Associates, LLC

Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 10036800396927
• NIH Device Record Key: 31ab3c3c-2049-4cc1-8719-d0a583006bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOPCARE
• Version Model Number: 87-639-000
• Catalog Number: 87-639-000
• Company DUNS: 072943876
• Company Name: Topco Associates, LLC
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036800396920 [Primary]
GS1	10036800396927 [Package]; Contains: 00036800396920; Package: Inner/Master Carton [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962520

FDA Product Code

• OZK: Thermometer, Exhaled Breath

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-18
• Device Publish Date: 2016-09-12

On-Brand Devices [TOPCARE]

• 10036800326719: TOPCO ZOO TEMPS
• 10036800334110: TOPCARE PREMIUM DIGITAL BLOOD PRESSURE MONITOR
• 10036800334103: TOPCARE STANDARD DIGITAL BPM ARM
• 00036800334090: TOPCARE PREMIUM WRIST BLOOD PRESSURE MONITOR WRIST
• 10036800404622: Hi-Tech Mint Flosser
• 10036800404615: Hi-Tech Mint Flosser
• 00036800563315: 55yd Waxed Floss
• 00036800384439: 100yd Mint Floss
• 00036800384422: 100yd Unwaxed Floss
• 00036800384415: 100yd Waxed Floss
• 10036800466590: Dual Zone Adv Clean Power Toothbrush
• 10036800461410: Hi-Tech mint Flosser
• 10036800461403: SuperSlip Mint Flossers
• 10036800442242: Dental Tool Kit
• 10036800410302: Classic Mouth Guard - Rest Assured
• 10036800405599: Polaris II Power Toothbrush
• 10036800400174: SuperSlip Mint Flossers
• 00036800174399: 50M Hi-Tech Mint Floss
• 00036800384392: 40M Extra Comfort Floss
• 00036800410275: Easy Flex Total Power Toothbrush
• 10036800624396: REGULAR MAXIPAD w/ WINGS UNSCENTED 18CNT
• 10036800624389: LONG SUPER MAXIPAD w/ WINGS UNSCENTED 16CNT
• 10036800442273: REGULAR THIN PANTILINER UNSCENTED 120CNT
• 10036800442266: LONG PANTILINER UNSCENTED 80CNT
• 10036800442259: MINI SHIELD UNSCENTED 54CNT
• 10036800391465: REGULAR THIN PANTILINER UNSCENTED 60CNT
• 10036800391458: LONG SUPER MULTI-CHANNEL WINGLESS MAXIPAD UNSCENTED 48CNT
• 10036800391441: EXTRA HEAVY OVERNIGHT MAXIPAD UNSCENTED 20CNT
• 10036800316475: LONG PANTILINER UNSCENTED 40CNT
• 10036800316468: REGULAR PANTILINER UNSCENTED 64CNT
• 10036800296975: LONG SUPER ULTRA THIN MAXIPAD W/ WINGS UNSCENTED 16CNT
• 10036800296968: REGULAR ULTRA THIN MAXIPAD w/ WINGS UNSCENTED 18CNT
• 10036800281667: LONG SUPER MULTI-CHANNEL WINGLESS MAXIPAD UNSCENTED 24CNT
• 10036800182124: REGULAR WINGLESS MAXIPAD UNSCENTED 24CNT
• 10036800116877: MINI SHIELD SCENTED 22CNT
• 10036800115818: MINI SHIELD UNSCENTED 22CNT
• 10036800083803: LONG SUPER ULTRA THIN MAXIPAD W/ WINGS UNSCENTED 32CNT
• 10036800083797: OVERNIGHT ULTRA THIN MAXIPAD W/ WINGS UNSCENTED 28CNT
• 10036800057460: REGULAR MULTI-CHANNEL WINGLESS MAXIPAD UNSCENTED 24CNT
• 10036800057453: REGULAR MULTI-CHANNEL WINGLESS MAXIPAD SCENTED 24CNT
• 10036800057446: REGULAR ULTRA THIN MAXIPAD W/WINGS UNSCENTED 36CNT
• 10036800057439: OVERNIGHT MAXIPAD w/ WINGS UNSCENTED 28CNT
• 10036800057422: LONG SUPER MAXIPAD W/ WINGS UNSCENTED 32CNT
• 10036800041391: OVERNIGHT MAXIPAD w/ WINGS UNSCENTED 14CNT
• 10036800041384: OVERNIGHT ULTRA THIN MAXIPAD w/ WINGS UNSCENTED 14CNT
• 00036800462632: Power Toothbrush, Cat in the Hat
• 20036800451838: TOPCARE 2-SECOND FLEX TIP DIGITAL THERMOMETER
• 10036800023427: TOPCARE PULSE OXIMETER
• 20036800477982: TOPCARE 30-SECOND RIGID TIP DIGITAL THERMOMETER
• 10036800398297: TOPCO INFRARED MULTIFUNCTION THERMOMETER