FDA UDI
In Commercial Distribution
🇺🇸 United States
WATTSON
DI: 10841156108885
·
Model: IPN916283
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WATTSON
- Primary DI
- 10841156108885
- Version / Model
- IPN916283
- Catalog Number
- 2250
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 2
- Public Version Date
- 2024-01-22
- Public Version Status
- Update
- Public Device Record Key
- adc5be52-50ec-413d-9e41-0d6aa0803b98
Device Description
Wattson Temporary Pacing Guidewire Pouch
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
- MR Unsafe
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQX | Wire, guide, catheter | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64611 | Temporary cardiac pacing guidewire | A long, thin, dual-purpose wire intended to be percutaneously placed into the heart to: 1) function as a guide for the introduction, positioning, and/or operation of an interventional device (e.g., balloon catheter, aortic valve introducer); and 2) deliver temporary rapid pacing stimuli to the heart, typically to control left ventricular pressure while the aortic valve is obstructed during a heart valve repair/replacement procedure. It includes electrodes and may be of pigtail design. Devices associated with proximal electric connection (e.g., mains power cable, transformer) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20841156108882 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 10841156108885 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]