FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Mapcath stylet
DI: 10815149025268
·
Model: 60-2011
·
CORPAK MEDSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mapcath stylet
- Primary DI
- 10815149025268
- Version / Model
- 60-2011
- Catalog Number
- 60-2011
- Company Name
- CORPAK MEDSYSTEMS, INC.
- Labeler DUNS
- 147530323
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-04
- Public Version
- 3
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 8d1ec068-7d5d-4a2d-afe2-0aee364fdfca
- Distribution End Date
- 2021-01-22
Device Description
stylet for use with Navigator
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 44119 | Intravascular catheter stylet magnet detector | An electrically-powered device designed to rapidly detect and confirm the location and orientation of the tip of a compatible, peripherally-inserted central catheter (PICC) or central venous catheter (CVC) stylet containing one or more small, specially-oriented magnets encapsulated at the distal end. It provides rapid feedback to healthcare personnel on the positioning of the catheter/stylet during initial placement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815149025265 | GS1 | 10 | Not in Commercial Distribution | 2021-01-22 | |
| Primary | 10815149025268 | GS1 |
Customer Contacts
- Phone
- +1(847)403-3400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 1.4 | French | |
| Device Size Text, specify | 1.4FR(0.46mm) X 106cm | ||
| Length | 106 | Centimeter |