FDA UDI
In Commercial Distribution
🇺🇸 United States
ForeSight
DI: 00690103208122
·
Model: FSESS
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ForeSight
- Primary DI
- 00690103208122
- Version / Model
- FSESS
- Catalog Number
- FSESS
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-07
- Public Version
- 1
- Public Version Date
- 2020-05-15
- Public Version Status
- New
- Public Device Record Key
- fac91c45-6527-4811-8d24-5bf7b34cdc2f
Device Description
ForeSight Small Sensor
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 46618 | Tissue saturation oximeter sensor, single-use | A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50690103208127 | GS1 | Shipper | 20 | In Commercial Distribution | |
| Primary | 00690103208122 | 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 | 2.5 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry place