FDA UDI
In Commercial Distribution
🇺🇸 United States
PRESEP
DI: 00690103163384
·
Model: X3820S
·
Edwards Lifesciences LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRESEP
- Primary DI
- 00690103163384
- Version / Model
- X3820S
- Catalog Number
- X3820S
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 96973006-a7c8-4b2b-9973-5f23370f4033
Device Description
PRESEP OXIMETRY CATHETER SET 8.5F 20CM
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQE | CATHETER, OXIMETER, FIBEROPTIC | Cardiovascular | 870.1230 | 2 |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION | Cardiovascular | 870.1435 | 2 |
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | Cardiovascular | 870.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31659 | Oximeter catheter, single-use | A flexible tube containing a fibreoptic bundle designed to conduct light at a selected wavelength through blood to detect the reflected or scattered light for the estimation of blood oxygen concentration. It detects with a sensor at its distal end and is used in conjunction with an oximeter for oxygen concentration calculation. This device is also known as a Swan-Ganz catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103163384 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | EXTERIOR DIAMETER: 8.5 F (2.8 MM), USABLE LENGTH: 20 CM, NUMBER OF LUMENS: 3, RECOMMENDED GUIDEWIRE SIZE: 0.032" (0.81 MM) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE.