Application Set
Catalogue number 0607110, listed by Radiometer Basel AG, Switzerland, under Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 Basel AG, Switzerland |
|---|---|
| FDA product code | KLK |
| Device type | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2500 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2022-06-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 30 °C |
| Distribution end date | 2019-06-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0607110 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | Philips Medizin Systeme Böblingen GmbH | 4 |
| Adhesive rings | Radiometer Basel AG | 2 |
| TC 560 Contact Liquid | Perimed AB | 1 |
| Calibration Gas 2 | Radiometer Medical APS | 1 |
| Contact gel | Radiometer Medical APS | 1 |
| Calibration Gas | Radiometer Basel AG | 1 |
| TC 555 Fixation Ring for tcpO2/CO2 – Extra Strength Adhesive | Perimed AB | 1 |
| Philips Transcutaneous pO2/pCO2 Parameter Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Supplies for Combi *M 82 | Radiometer Basel AG | 1 |
| Combi *M sensor 82 | Radiometer Basel AG | 1 |
| TC 550 Fixation Ring for tcpO2/CO2 | Perimed AB | 1 |
| Application set Neonatal | Radiometer Basel AG | 1 |
Showing 12 of 13. All products under Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
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.