FDA UDI
In Commercial Distribution
🇺🇸 United States
Piccolo Medical
DI: 00860002238531
·
Model: FGS-15-640
·
Piccolo Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Piccolo Medical
- Primary DI
- 00860002238531
- Version / Model
- FGS-15-640
- Catalog Number
- FGS-15-640
- Company Name
- Piccolo Medical, Inc.
- Labeler DUNS
- 116996235
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- 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
- 64276db5-409d-4d06-be17-72c3cb969f7a
Device Description
ECGuide Connector (20-Pack)
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61729 | Central venous catheter navigation system support kit | A collection of sterile, noninvasive devices intended to assist use of a central venous catheter navigation system during electrocardiographic (ECG) supported guidance and positioning of a central venous catheter. The kit is dedicated to ECG-supported catheter navigation and typically includes system components (e.g., ECG leads, connectors) and other supportive devices (e.g., cable cover). The kit is intended to support the procedure which involves the catheter used as an intravascular electrode whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00860002238579 | GS1 | ||||
| Primary | 00860002238531 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius