POCone Infrared Spectrophotometer

GUDID 04987035343417

The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.

OTSUKA ELECTRONICS CO.,LTD.

Infrared spectrometry breath analyser IVD

• Primary Device ID: 04987035343417
• NIH Device Record Key: e70075ce-a2d5-4d3e-a4f3-229a090f0d84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POCone Infrared Spectrophotometer
• Version Model Number: POCone
• Company DUNS: 695318717
• Company Name: OTSUKA ELECTRONICS CO.,LTD.
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987035343417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041148

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

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: 2019-11-07
• Device Publish Date: 2019-10-30

Devices Manufactured by OTSUKA ELECTRONICS CO.,LTD.

• 04987035343417 - POCone Infrared Spectrophotometer: 2019-11-07The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
• 04987035343417 - POCone Infrared Spectrophotometer: 2019-11-07 The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO
• 04987035388517 - POC-AS10 Auto sampler: 2019-11-07 The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared S