FDA UDI
In Commercial Distribution
🇺🇸 United States
FLOTRAC
DI: 00690103194609
·
Model: MHD8
·
Edwards Lifesciences LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLOTRAC
- Primary DI
- 00690103194609
- Version / Model
- MHD8
- Catalog Number
- MHD8
- 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
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a71a5225-47f0-4415-8631-16e1044d0fa5
Device Description
FLOTRAC SENSOR
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION | Cardiovascular | 870.1435 | 2 |
| DQE | CATHETER, OXIMETER, FIBEROPTIC | Cardiovascular | 870.1230 | 2 |
| DRS | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR | Cardiovascular | 870.2850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35927 | Invasive-pressure external transducer, single-use | A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103194609 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | PRESSURE TUBING: 84 IN (213 CM) LENGTH |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE.