Rectal Digital Thermometer 16816

GUDID 20612606001547

Dual Scale Rectal Digital Thermometer with 20 Probe Covers, 60 second read

KERMA MEDICAL PRODUCTS, INC.

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 20612606001547
• NIH Device Record Key: 2630d43e-b521-4eae-93ae-c8a07e1d9696
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rectal Digital Thermometer
• Version Model Number: 16816
• Catalog Number: 16816
• 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	00612606001543 [Primary]
GS1	20612606001547 [Package]; Contains: 00612606001543; 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: 2018-07-06 Rectal Temperature Digital Thermometer
• 20612606001547 - Rectal Digital Thermometer: 2018-07-06Dual Scale Rectal Digital Thermometer with 20 Probe Covers, 60 second read
• 20612606001547 - Rectal Digital Thermometer: 2018-07-06 Dual Scale Rectal Digital Thermometer with 20 Probe Covers, 60 second read