| Primary Device ID | 00852004007000 |
| NIH Device Record Key | 68917f9b-cbe2-4cf9-9380-d5948ab19199 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endophys Blood Pressure Monitor |
| Version Model Number | BPM-20-SC |
| Company DUNS | 079776997 |
| Company Name | ENDOPHYS HOLDINGS, LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852004007000 [Primary] |
| DSK | Computer, Blood-Pressure |
| 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 | 2016-09-22 |
| 00852004007215 - Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No Guidewire | 2024-03-08 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer |
| 00852004007239 - Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire | 2024-03-08 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer |
| 00852004007086 - Endophys Pressure Sensing Sheath Kit - 8F 11 CM | 2023-11-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer |
| 10852004007069 - Endophys Pressure Sensing Sheath Kit - 6F 12 CM | 2023-11-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic transducer, a vesse |
| 10852004007076 - Endophys Pressure Sensing Sheath Kit - 8F 25 CM | 2023-11-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer |
| 00852004007000 - Endophys Blood Pressure Monitor | 2018-07-06Device used in the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a cannula. |
| 00852004007000 - Endophys Blood Pressure Monitor | 2018-07-06 Device used in the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introd |
| 00852004007017 - Endophys Pressure Sensing Sheath Kit-6F | 2018-07-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer |
| 00852004007024 - Endophys Pressure Sensing Sheath Kit-6F | 2018-07-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer |