FDA UDI
In Commercial Distribution
🇺🇸 United States
Sherlock 3CG+ TCS System Version 3.2.0
DI: 00801741223129
·
Model: Sherlock 3CG+ TCS Software Version 3.2.0
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sherlock 3CG+ TCS System Version 3.2.0
- Primary DI
- 00801741223129
- Version / Model
- Sherlock 3CG+ TCS Software Version 3.2.0
- Catalog Number
- Sherlock 3CG+ TCS Software Version 3.2.0
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-13
- Public Version
- 1
- Public Version Date
- 2022-01-21
- Public Version Status
- New
- Public Device Record Key
- b0399612-356e-4b3b-864f-ea35d5f858de
Device Description
CVAD Tip Confirmation 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61667 | Central venous catheter navigation system, electrocardiographic/magnetic | An assembly of devices intended to use electrocardiographic (ECG) and magnetic data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It includes a mains electricity (AC-powered) control unit [with internal rechargeable batteries] and visual display, ECG skin electrodes, lead(s) and cable(s), a magnetic sensor to be placed on the patient’s chest, and a remote control. The system is designed to be used with a dedicated catheter/stylet (not included) which functions as an intravascular ECG electrode and magnet whose position is detected by the sensor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741223129 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]