FDA UDI
In Commercial Distribution
🇺🇸 United States
POCone Infrared Spectrophotometer
DI: 04987035343417
·
Model: POCone
·
OTSUKA ELECTRONICS CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POCone Infrared Spectrophotometer
- Primary DI
- 04987035343417
- Version / Model
- POCone
- 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
- e70075ce-a2d5-4d3e-a4f3-229a090f0d84
Device Description
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.
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 | 04987035343417 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041148 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity