FDA UDI
In Commercial Distribution
🇺🇸 United States
Accuryn Temperature Cable
DI: 00850019755008
·
Model: FGN-06-100779
·
POTRERO MEDICAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accuryn Temperature Cable
- Primary DI
- 00850019755008
- Version / Model
- FGN-06-100779
- Catalog Number
- FGN-06-100779
- Company Name
- POTRERO MEDICAL, INC.
- Labeler DUNS
- 079428290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-19
- Public Version
- 3
- Public Version Date
- 2023-08-17
- Public Version Status
- Update
- Public Device Record Key
- eff0f04f-0239-4781-8d3d-fd984489e19d
Device Description
The Reusable Temperature Cable connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | 876.5130 | 2 |
| PHU | Intra-Abdominal Pressure Monitoring Device | Unknown | U | |
| EXY | Uroflowmeter | Gastroenterology, Urology | 876.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850019755008 | GS1 |
Customer Contacts
- Phone
- 833-222-8796
- [email protected]