FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CNS-2101 Central Monitor
DI: 04931921017166
·
Model: CNS-2101
·
NIHON KOHDEN CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CNS-2101 Central Monitor
- Primary DI
- 04931921017166
- Version / Model
- CNS-2101
- Catalog Number
- CNS-2101
- Company Name
- NIHON KOHDEN CORPORATION
- Labeler DUNS
- 690568050
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-01
- Public Version
- 2
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- 081b4450-55f1-4489-8caf-6a025acec545
- Distribution End Date
- 2023-10-01
Device Description
Central Monitor
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | 870.2300 | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Cardiovascular | 870.2060 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38470 | Centralized patient monitor | A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04931921017166 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223567 | 000 |