FDA UDI
In Commercial Distribution
🇺🇸 United States
CORTRAK 2EAS
DI: 10815149024599
·
Model: 20-0951
·
CORPAK MEDSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORTRAK 2EAS
- Primary DI
- 10815149024599
- Version / Model
- 20-0951
- Catalog Number
- 20-0951
- Company Name
- CORPAK MEDSYSTEMS, INC.
- Labeler DUNS
- 147530323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4598848f-23d9-418f-ab28-602c369a1b12
Device Description
CORTRAK 2 Enteral Access System Accessory Kit
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59078 | Enteral tube tracking system | A mains electricity (AC-powered) portable electronic device assembly, typically with rechargeable battery, designed to detect, record, and display an electromagnetic (EM) signal emitted from a transmitter in an enteral feeding tube stylet to facilitate the placement of the enteral tube, by providing a graphic display representing the path of the tube tip. It consists of an electromagnetic receiver placed on the epigastrium, a visual display/control unit which displays real-time anterior and cross-sectional representational views of the transmitter location and track, and a separately supplied single-use enteral feeding tube stylet which incorporates an electromagnetic transmitter in the tip. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815149024599 | GS1 |
Customer Contacts
- Phone
- +1(847)403-3400
- [email protected]