cap-ONE TG-970P

GUDID 00841983102653

CO2 Sensor Kit, CapOne 2nd Gen

NIHON KOHDEN AMERICA, INC.

Carbon dioxide monitor

• Primary Device ID: 00841983102653
• NIH Device Record Key: 9e5f8a67-1f12-4213-90f0-9cf8fac63f07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cap-ONE
• Version Model Number: TG-970P
• Catalog Number: TG-970P
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983102653 [Primary]

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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: 2016-09-19

On-Brand Devices [cap-ONE]

• 00841983102653: CO2 Sensor Kit, CapOne 2nd Gen
• 00841983102646: CO2 Sensor Kit for Sleep, CapOne
• 00841983102639: CO2 Sensor Kit, CapOne
• 10841983102797: EtCO2 Nasal / Oral Probe w/ pressure control, pediatric
• 10841983102780: EtCO2 Nasal / Oral Probe w/ pressure control, Adult
• 10841983102773: EtCO2 Nasal / Oral Probe, Pediatric
• 10841983102766: EtCO2 Nasal / Oral Probe, Adult
• 10841983101561: Cap-ONE Mask, Infant
• 10841983101554: Cap-ONE Mask, Pediatric
• 10841983101516: Nasal adapter for TG-920P (oxygen cannula adjustment)