POC-AS10 Auto sampler

Basic Information

• Brand Name: POC-AS10 Auto sampler
• Primary DI: 04987035388517
• Version / Model: POC-AS10
• Company Name: OTSUKA ELECTRONICS CO.,LTD.
• Labeler DUNS: 695318717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-30
• Public Version: 1
• Public Version Date: 2019-11-07
• Public Version Status: New
• Public Device Record Key: 65282e18-d712-4813-9d8c-c80d5224c5aa

Device Description

The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	862.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17474	Infrared spectrometry breath analyser IVD	An electrically-powered laboratory or point-of-care instrument designed to use infrared spectrometry technology for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is typically used to measure analytes such as ingested carbon isotopes that have been metabolized (e.g., 13C, 14C) to establish a correlation with metabolic profiles or disorders [e.g., gastrointestinal H. pylori infection]. The device operates with minimal technician involvement and complete automation of all procedural steps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987035388517	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092817	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity