FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuTab
DI: 00850019755015
·
Model: FGN-06-101581
·
POTRERO MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AccuTab
- Primary DI
- 00850019755015
- Version / Model
- FGN-06-101581
- Catalog Number
- FGN-06-101581
- Company Name
- POTRERO MEDICAL, INC.
- Labeler DUNS
- 079428290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-13
- Public Version
- 2
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 54cfce24-3106-42a1-a2a0-ae02313e813d
Device Description
AccuTab is a tablet with associated software (AccuData) that connects to the Accuryn Monitor. The tablet is an extension of the Accuryn Monitor and only displays the data that already exists on the Accuryn Monitor. AccuTab with AccuData is solely intended to transfer, store, convert forms, and display medical device data from the Accuryn Monitor.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63634 | Multi-parameter urinary monitoring system control unit | An electrically-powered component of a multi-parameter urinary monitoring system intended to process and display measurements of urinary output, intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It is a control unit with a monitor connected to a dedicated disposable catheter set (not included) and is typically used in an intensive care setting to manage acute renal failure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850019755015 | GS1 |
Customer Contacts
- Phone
- 1-833-222-8796
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221020 | 000 |