FDA UDI
In Commercial Distribution
🇺🇸 United States
cap-ONE
DI: 00841983102646
·
Model: TG-921T3
·
NIHON KOHDEN AMERICA, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- cap-ONE
- Primary DI
- 00841983102646
- Version / Model
- TG-921T3
- Catalog Number
- TG-921T3
- Company Name
- NIHON KOHDEN AMERICA, INC.
- Labeler DUNS
- 021063219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 77135dbc-2d6d-4bf2-8d9b-026ad51b8d63
Device Description
CO2 Sensor Kit for Sleep, CapOne
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | Neurology | 882.1870 | 2 |
| OLV | Standard polysomnograph with electroencephalograph | Neurology | 882.1400 | 2 |
| OLT | Non-normalizing quantitative electroencephalograph software | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31339 | Carbon dioxide monitor | A mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream". | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841983102646 | GS1 |
Customer Contacts
- Phone
- +1(800)325-0283
- [email protected]