Adhesive Rings N20 Kit
Adhesive rings N20 kit, dispenser incl. 1 roll of 250 adhesive rings 20 mm, 1x vial contact gel
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Radiometer Medical APS, Denmark |
|---|---|
| FDA product code | LKD |
| Device type | Monitor, Carbon-Dioxide, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2480 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2025-04-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 905-872 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TCM4x Cable | Radiometer Medical APS | 5 |
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 3 |
| TC pO2/pCO2 Membraning kit For TC electrode | Radiometer Medical APS | 2 |
| TC electrode | Radiometer Medical APS | 2 |
| Fixation kit N20 | Radiometer Medical APS | 1 |
| TC pO2/pCO2 electrode | Radiometer Medical APS | 1 |
| Calibration Gas | Radiometer Medical APS | 1 |
| TCM4XX ETX Serial adapter, cable for TCM4XX ETX | Radiometer Medical APS | 1 |
| TCM Tosca module | Radiometer Medical APS | 1 |
| Extension cable For TCM3 electrodes, 3m | Radiometer Medical APS | 1 |
| tc Sensor 84 | Radiometer Medical APS | 1 |
| Philips IntelliVue TcG10 | Philips Medizin Systeme Böblingen GmbH | 1 |
Showing 12 of 23. All products under Monitor, Carbon-Dioxide, Cutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093154 | 2010-02-05 |
| K043003 | 2005-03-01 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-02-20 | Class II | Under Investigation by firm | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance | 84 units | 2022-06-24 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840037 | 1986-11-19 | MODEL 515 NEONATAL MONIOTR | GE Medical Systems Information Technologies, Inc. |
| P850087 | 1986-11-14 | LITTON TRANSCUTANEOUS CO2 SYSTEM | Litton Datamedix |
| P820019 | 1986-03-03 | LIFESPAN(TM) 100 TCPCO2 MONITOR | Biochem International, Inc. |
| P810022 | 1985-11-21 | TCO2M MODEL 818 MONITOR | Novametrix Medical Systems, Inc. |
| P830008 | 1984-10-29 | CUTANIOUS GAS MONITOR | Sensor Medics Corp. |
| P820025 | 1984-04-18 | TCPCO2 MONITORING SYSTEM | Narco Scientific |
| P800043 | 1984-03-01 | RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO | Radiometer America, Inc. |
| P810037 | 1982-12-22 | KONTRON CUTANEOUS PCO2 MONITOR | Kontron Cardiovascular |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.