FDA UDI
In Commercial Distribution
🇺🇸 United States
Piccolo Medical
DI: 00860002238517
·
Model: FGN-15-634
·
Piccolo Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Piccolo Medical
- Primary DI
- 00860002238517
- Version / Model
- FGN-15-634
- Catalog Number
- FGN-15-634
- Company Name
- Piccolo Medical, Inc.
- Labeler DUNS
- 116996235
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-07
- Public Version
- 1
- Public Version Date
- 2025-11-17
- Public Version Status
- New
- Public Device Record Key
- 317f5621-4e1b-476a-bf9d-bb8b7916048d
Device Description
PM2 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
- 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 |
|---|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | 880.5970 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61730 | Central venous catheter navigation system control unit | A portable mains electricity (AC-powered) component of an electrocardiographic central venous catheter navigation system intended to process and display electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It is a control unit with a monitor (e.g., a dedicated touchscreen unit) intended to be connected to the appropriate ECG cables/leads/catheter (not included). The technique involves the catheter functioning as an intravascular ECG electrode (using the guidewire or intraluminal saline as a conductor) which, along with skin surface ECG data, provides feedback on catheter tip location. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860002238517 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius