FDA UDI
In Commercial Distribution
🇺🇸 United States
Kingst
DI: 06974774500063
·
Model: Capno-S
·
Beijing Kingst Commercial & Trade Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Kingst
- Primary DI
- 06974774500063
- Version / Model
- Capno-S
- Company Name
- Beijing Kingst Commercial & Trade Co., Ltd.
- Labeler DUNS
- 527224872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-02
- Public Version
- 1
- Public Version Date
- 2026-04-10
- Public Version Status
- New
- Public Device Record Key
- a0865a2c-bb58-4dba-a6d9-a5c1a1f2e121
Device Description
The CO2 Sidestream Module is intended to provide carbon dioxide and respiration rate noninvasive monitoring, the CO2 module is intended to be used together with the host with matched protocol.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46822 | Carbon dioxide sensor/cable | An assembly of electrical wires with a detector (typically infrared spectroscopic) at the distal end designed to connect a carbon dioxide (CO2) cuvette, or other form of translucent window placed in an anaesthetic or ventilatory breathing circuit, with a CO2 patient monitor, for the transmission of electrical signals to measure the CO2 concentration in gases expired by the patient. The proximal end of the device typically has a multi-pinned plug for insertion into the patient monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974774500063 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192488 | 000 |