cap-ONE

GUDID 14931921904043

Adult Cap-ONE Biteblock

NIHON KOHDEN CORPORATION

Carbon dioxide monitor

• Primary Device ID: 14931921904043
• NIH Device Record Key: e8dc8f15-a2f6-4d37-b14a-c5bf578a0c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cap-ONE
• Version Model Number: YG-227T
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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	04931921904046 [Unit of Use]
GS1	14931921904043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171765

FDA Product Code

• MNK: Endoscopic bite block

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: 2018-03-29
• Device Publish Date: 2017-10-30

On-Brand Devices [cap-ONE]

• 04931921902844: CO2 Sensor Kit, CapOne 2nd Gen
• 04931921885635: CO2 Sensor Kit, CapOne 2nd Gen
• 04931921865767: CO2 Sensor Kit for Sleep, CapOne
• 04931921865750: CO2 Sensor Kit, CapOne
• 14931921904043: Adult Cap-ONE Biteblock
• 14931921902568: cap-One mask, adult, large
• 14931921902551: cap-ONE mask, adult, large
• 14931921902544: cap-One mask, adult
• 14931921902537: cap-ONE mask, adult
• 14931921900373: EtCO2 Nasal / Oral Probe w/ pressure control, pediatric
• 14931921900359: EtCO2 Nasal / Oral Probe w/ pressure control, Adult
• 14931921895709: Cap-ONE Mask, Infant
• 14931921886202: Cap-ONE Mask, Pediatric
• 14931921883744: EtCO2 Nasal / Oral Probe, Pediatric
• 14931921883713: EtCO2 Nasal / Oral Probe, Adult
• 14931921869038: Nasal adapter for TG-920P (oxygen cannula adjustment)
• 04931921025727: CO2 Sensor Kit
• 04931921010334: cap-ONE Nasal Adapter, Pediatric, w/ Oxygen tube
• 04931921010303: cap-ONE Nasal Adapter, Pediatric
• 04931921010273: cap-ONE Nasal Adapter, Adult, w/ Oxygen tube
• 04931921010235: cap-ONE Nasal Adapter, Adult