N/A

GUDID 04931921004838

SpO2 Adapter

NIHON KOHDEN CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 04931921004838
• NIH Device Record Key: 8c5445ec-a7b9-4a8b-99c6-730086d5a43c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: JL-639P
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• 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: false
• Serial Number: true
• 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: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: +1(800)325-0283
• Email: VitalSignsTechSupport@nihonkohden.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04931921004838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080342

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: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-04-09

On-Brand Devices [N/A]

• 04931921119761: EEG Acquisition Kit
• 04931921004838: SpO2 Adapter
• 04931921003091: Communication Cable for CAS Medical Systems FORE-SIGHT ELITE
• 04931921116791: Unit holder
• 04931921114995: Serial cable, 2.5m
• 04931921007334: DAU connection cable extension kit
• 04931921004821: HDMI cable, 50m
• 04931921004814: HDMI cable, 30m
• 04931921004807: HDMI cable, 10m
• 04931921004760: Unit holder
• 04931921004753: GF holder
• 04931921004746: IF holder
• 04931921004739: Recorder holder
• 04931921004722: Channel adapter
• 04931921004715: Adapter
• 04931921004685: Recorder cable, 0.35m
• 04931921004678: Recorder cable, 1.5m
• 04931921004630: DAU connection cable, 10m
• 04931921004623: DAU connection cable, 5m
• 04931921004616: DAU connection cable, 2.8m
• 04931921004609: DAU connection cable, 0.9m
• 04931921002346: Adapter
• 04931921002339: Unit holder
• 04931921002322: Holder
• 04931921002315: Unit holder
• 04931921002308: Display connection cable (HDMI), 5m
• 04931921002292: Display connection cable (HDMI), 10m
• 04931921002285: Display connection cable (DVI-D – DVI-I), 10m
• 04931921002278: Display connection cable (DVI-D – RGB), 5m
• 04931921002261: Display connection cable (DVI-D – RGB), 2m
• 04931921002254: Display connection cable (DVI-D – HDMI), 5m
• 04931921002247: Display connection cable (DVI-D – DVI-D), 5m
• 04931921002230: Display connection cable (DVI-D – DVI-D), 2.5m
• 04931921002223: SSD expansion board
• 04931921002087: Multi amp unit