KenTeK KT-1000

GUDID 00810003751164

KENTEK FINGER PULSE OXIMETER WITH LED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF.

KENTRON HEALTHCARE, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00810003751164
• NIH Device Record Key: a3c9ad71-952d-4da4-b11d-9871ce2fa7b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KenTeK
• Version Model Number: KT-1000
• Catalog Number: KT-1000
• 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	00810003751164 [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