FDA UDI
In Commercial Distribution
🇺🇸 United States
FORESIGHT ELITE
DI: 00690103208597
·
Model: FSEO2004
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FORESIGHT ELITE
- Primary DI
- 00690103208597
- Version / Model
- FSEO2004
- Catalog Number
- FSEO2004
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-10
- Public Version
- 1
- Public Version Date
- 2021-11-18
- Public Version Status
- New
- Public Device Record Key
- 791b5065-5c3c-444b-84b6-866ef0fc8148
Device Description
FORESIGHT ELITE OXIMETER PREAMP CABLE, 4M
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 |
|---|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64392 | Electrical-only medical device connection adaptor, reusable | A device intended to allow electrical connection of incompatible plugs/sockets on related medical devices (e.g., generator and controller) and/or cables. This device will typically be used when the system components are from different manufacturers or using different technologies, and the original connectors are not compatible; it has no additional non-electrical conduction or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103208597 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143675 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.0000 | Meter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE