Rectal Temperature Digital Thermometer 16813

GUDID 20612606001530

Rectal Temperature Digital Thermometer

KERMA MEDICAL PRODUCTS, INC.

Intermittent electronic patient thermometer

• Primary Device ID: 20612606001530
• NIH Device Record Key: ed4a891d-91c1-4f1f-b6c0-fd0edcec4d48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rectal Temperature Digital Thermometer
• Version Model Number: 16813
• Catalog Number: 16813
• Company DUNS: 787328772
• Company Name: KERMA MEDICAL PRODUCTS, 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612606001536 [Primary]
GS1	20612606001530 [Package]; Contains: 00612606001536; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940686

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2018-07-06
• Device Publish Date: 2017-08-18

Devices Manufactured by KERMA MEDICAL PRODUCTS, INC.

• 00612606001505 - Dual Scale Digital Thermometer: 2018-07-06 Dual Scale Digital Thermometer, 60 second read, for oral, rectal, or axillary use
• 20612606001516 - Oral Temperature Digital Thermometer: 2018-07-06 Dual Scale Oral Digital Thermometer, 60 second read
• 20612606001523 - Oral Temperature Digital Thermometer: 2018-07-06 Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read
• 20612606001530 - Rectal Temperature Digital Thermometer: 2018-07-06Rectal Temperature Digital Thermometer
• 20612606001530 - Rectal Temperature Digital Thermometer: 2018-07-06 Rectal Temperature Digital Thermometer
• 20612606001547 - Rectal Digital Thermometer: 2018-07-06 Dual Scale Rectal Digital Thermometer with 20 Probe Covers, 60 second read