FDA UDI
In Commercial Distribution
🇺🇸 United States
Endophys Blood Pressure Monitor
DI: 00852004007000
·
Model: BPM-20-SC
·
ENDOPHYS HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endophys Blood Pressure Monitor
- Primary DI
- 00852004007000
- Version / Model
- BPM-20-SC
- Company Name
- ENDOPHYS HOLDINGS, LLC
- Labeler DUNS
- 079776997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 68917f9b-cbe2-4cf9-9380-d5948ab19199
Device Description
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSK | Computer, Blood-Pressure | Cardiovascular | 870.1110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36550 | Patient monitoring system module, blood pressure, invasive | A small unit dedicated to the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a catheter. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852004007000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141615 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 65 Degrees Celsius