| Primary Device ID | 07640121880933 |
| NIH Device Record Key | 80b9ce17-6340-4a7f-9b74-6291ecd07272 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Membrane Changer (single-use) / single unit |
| Version Model Number | MC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *during transport between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640121880933 [Primary] |
| GS1 | 17640121880930 [Package] Package: Box [3 Units] In Commercial Distribution |
| DPZ | Oximeter, Ear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2021-02-28 |
| 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 | 2021-03-08The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use. |
| 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 |