JT-950P

GUDID 00841983102288

CO connection cord Bath probe and inline sensor methods

NIHON KOHDEN AMERICA, INC.

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00841983102288
• NIH Device Record Key: 86d58794-0fc7-4930-ad1f-3df1a141f9a6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: JT-950P
• Catalog Number: JT-950P
• Company DUNS: 021063219
• Company Name: NIHON KOHDEN AMERICA, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com
• Phone: +1(800)325-0283
• Email: info@nkusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983102288 [Primary]

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2020-02-06
• Device Publish Date: 2016-09-19

Devices Manufactured by NIHON KOHDEN AMERICA, INC.

• 10841983103947 - NA: 2023-10-09 PAPER, ECG1250, 9020, 10 PADS
• 10841983103954 - NA: 2023-10-09 PAPER, ECG1350, 9130, 10 PADS
• 10841983103930 - NA: 2023-08-17 PAPER, ECG-1550A, 10 PADS
• 00841983104336 - NK-HealthProtect Wireless Surge Solution: 2021-12-31 Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring
• 10841983102667 - NA: 2021-11-10 SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable
• 10841983102674 - NA: 2021-11-10 SpO2 probe Child, infant (from 3 to 15 kg) Toe, disposable
• 10841983102704 - BluPRO®: 2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 80cm cable
• 10841983102711 - BluPRO®: 2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable