Standard Starter Set
Standard Starter Set contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer…
Standard Starter Set contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) Service Gas (GAS-0812)
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Aimooe Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
Record
| Listed by | Sentec AG, Switzerland |
|---|---|
| FDA product code | LPP |
| Device type | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2500 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-08-31 |
| Record revised | 2026-03-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: during transport: 0-50°C; Storage environment humidity 25 to 60 % RH; Storage environment temperature 10 to 30 °C |
| Distribution end date | 2020-03-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSET | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PF 6840-4 TC Remote Panel 4 Channels | Perimed AB | 1 |
| PSG Cable C | Sentec AG | 1 |
| PF 6840-2 TC Remote Panel 2 Channels | Perimed AB | 1 |
| Connector kit For ETC hyperbaric chamber | Radiometer Medical APS | 1 |
| PSG Cable A | Sentec AG | 1 |
| O2 module for the TCM4XX Series | Radiometer Medical APS | 1 |
| PSG Cable E | Sentec AG | 1 |
| TC electrode | Radiometer Medical APS | 1 |
| PSG Cable M | Sentec AG | 1 |
| Contact Gel | Sentec AG | 1 |
| Fixation Kit For TC electrodes | Radiometer Medical APS | 1 |
| Isolation Transformer 100-120V | Sentec AG | 1 |
Showing 12 of 34. All products under Monitor, Oxygen, Cutaneous, For Uses Other Than 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.