| Primary Device ID | 00852004007239 |
| NIH Device Record Key | 31ccc09c-3543-40be-8332-f5705cb05efa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire |
| Version Model Number | PSS-10-0811200-SCN-NGW |
| 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 | 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 |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com | |
| Phone | 1-469-828-5119 |
| support@endophys.com |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852004007222 [Primary] |
| GS1 | 00852004007239 [Package] Contains: 00852004007222 Package: Shipper [5 Units] In Commercial Distribution |
| DXO | Transducer, Pressure, Catheter Tip |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
| 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 | 2024-03-08The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer, and a vessel dilator. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedures requiring vascular access. |
| 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 | 2018-07-06 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 |