FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe® Catheter Cable Support
DI: 07540162100352
·
Model: 601-00067
·
Kardium Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Globe® Catheter Cable Support
- Primary DI
- 07540162100352
- Version / Model
- 601-00067
- Company Name
- Kardium Inc
- Labeler DUNS
- 248480043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-15
- Public Version
- 1
- Public Version Date
- 2025-09-23
- Public Version Status
- New
- Public Device Record Key
- 1d8c5437-25d9-4f9c-9dda-4fc9391b78f0
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
- Yes
- 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 |
|---|---|---|---|---|
| QWA | Cardiovascular Delivery Catheter System Positioning And Stabilization Device | Cardiovascular | 870.3955 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42410 | Electrical cable/lead holder | A device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07540162100369 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 07540162100352 | GS1 |