FDA UDI
In Commercial Distribution
🇺🇸 United States
COOLIEF* Cooled Radiofrequency Sterile Tube Kit
DI: 00193493096930
·
Model: 09693
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COOLIEF* Cooled Radiofrequency Sterile Tube Kit
- Primary DI
- 00193493096930
- Version / Model
- 09693
- Catalog Number
- TDA-TBK-1
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-01
- Public Version
- 2
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 8b366166-5701-40c6-a86d-3455cc6065c8
Device Description
COOLIEF* Cooled Radiofrequency Sterile Tube Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXI | PROBE, RADIOFREQUENCY LESION | Neurology | 882.4725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44772 | Cardiac ablation system irrigation tubing set | A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00193493096930 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]