| Primary Device ID | 07640121880490 |
| NIH Device Record Key | 6a3fe8a2-e1ba-411b-8983-8524ee48b594 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Membrane Changer Set |
| Version Model Number | MC-SET |
| Company DUNS | 480797856 |
| Company Name | SenTec AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *during transport: 0-50°C |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640121880490 [Primary] |
| DPZ | Oximeter, Ear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-31 |
| 17640121881036 - Non-Adhesive Wrap | 2023-07-31 Sentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin fo |
| 07640121880957 - Patient Application Kit with Ear Clip for mature/intact skin | 2021-10-04 A combination of single-use products intended to attach the Sentec sensors to the earlobe of the patient, recommended for patien |
| 17640121880961 - Patient Application Kit for mature intact skin | 2021-10-04 A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for ad |
| 17640121880978 - Patient Application Kit for sensitive/fragile skin | 2021-10-04 A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for ad |
| 07640121880889 - SDM Water Protection Cover | 2021-09-02 This cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2). |
| 07640121880902 - Isolation Transformer 100-120V | 2021-05-13 Isolates the SDM from mains for use in home use environments. |
| 07640121880933 - Membrane Changer (single-use) / single unit | 2021-03-08 The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane mus |
| 17640121880817 - Ear Clip easy | 2020-04-08 Single patient use sensor application ear clip, recommended for adult, pediatric and neonatal patients with mature/intact skin |