FDA UDI
In Commercial Distribution
🇺🇸 United States
Accuryn Temperature Cable Adapter
DI: 00850019755206
·
Model: FGN-06-102306
·
POTRERO MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accuryn Temperature Cable Adapter
- Primary DI
- 00850019755206
- Version / Model
- FGN-06-102306
- Catalog Number
- FGN-06-102306
- 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
- 22960468-026a-4504-a401-f4ad7a34fbc0
Device Description
A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter is an accessory of the Accuryn Monitoring System.
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 |
|---|---|---|---|---|
| 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 | 00850019755206 | GS1 |
Customer Contacts
- Phone
- 833-222-8796
- [email protected]