FDA UDI
In Commercial Distribution
🇺🇸 United States
CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube
DI: 10815149020959
·
Model: 42-9368TRAK2
·
CORPAK MEDSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube
- Primary DI
- 10815149020959
- Version / Model
- 42-9368TRAK2
- Catalog Number
- 42-9368TRAK2
- Company Name
- CORPAK MEDSYSTEMS, INC.
- Labeler DUNS
- 147530323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 31deb8ff-958c-49e9-b1ac-c780756e0c9d
Device Description
Feeding tube with stylet for use with CORTRAK 2 Enteral Access System
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
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 59081 | Enteral tube tracking system transmitter stylet | A non-sterile, thin, flexible wire with an electromagnetic (EM) transmitter at the distal end that is a component of an enteral tube tracking system and intended to be used as a stylet for an enteral feeding tube with which it is supplied. It is designed to facilitate the placement of the enteral tube by providing a signal used to create a graphic display representing the path of the tube tip. During use it is typically connected to a visual display/control unit and is used with an electromagnetic transmission receiver placed on the epigastrium. This is a reusable device intended for single-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815149020956 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10815149020959 | GS1 |
Customer Contacts
- Phone
- +1(847)403-3400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8FR (2.7mm) X 36" (91cm) | ||
| Catheter Gauge | 8 | French | |
| Length | 36 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No