FDA UDI
In Commercial Distribution
🇺🇸 United States
cable
DI: 00690103218411
·
Model: 896600022
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- cable
- Primary DI
- 00690103218411
- Version / Model
- 896600022
- Catalog Number
- 896600022
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-31
- Public Version
- 1
- Public Version Date
- 2023-11-08
- Public Version Status
- New
- Public Device Record Key
- 641b5b67-f694-4a39-9015-e6dea6e79371
Device Description
896600022 CABLE ASSY,EW PRUCKA
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | 870.2870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37340 | General-purpose patient temperature probe, reusable | A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103218411 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142749 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 162.0000 | Inch |