FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 10680651458022
·
Model: 45802
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Halyard
- Primary DI
- 10680651458022
- Version / Model
- 45802
- Catalog Number
- 20-9432TRAK2
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-13
- Public Version
- 3
- Public Version Date
- 2018-11-16
- Public Version Status
- Update
- Public Device Record Key
- e055d253-a4de-4229-826a-647683740fd6
Device Description
HALYARD* CORTRAK* 2 Nasogastric/Nasointestinal Feeding Tube with Electromagnetic Transmitting Stylet
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 30680651458026 | GS1 | CS | 10 | In Commercial Distribution | |
| Primary | 10680651458022 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 12 | French |