KenTeK KT-2000

GUDID 00810003751171

KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, PR WAVEFORM DISPLAY, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF, FOUR DIRECTIONS DISPLAY.

KENTRON HEALTHCARE, INC.

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00810003751171
• NIH Device Record Key: 16d242dd-963d-4ea0-b49e-a8825dd89945
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KenTeK
• Version Model Number: KT-2000
• Catalog Number: KT-2000
• Company DUNS: 618825723
• Company Name: KENTRON HEALTHCARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM
• Phone: 615-384-0573
• Email: KENTRON@KENTRONMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810003751171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141105

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-19
• Device Publish Date: 2018-11-18

On-Brand Devices [KenTeK]

• 00810003751171: KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE R
• 00810003751164: KENTEK FINGER PULSE OXIMETER WITH LED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RA