FDA UDI
In Commercial Distribution
🇺🇸 United States
PhysioFlow
DI: 03760125071213
·
Model: Q-Link
·
MANATEC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PhysioFlow
- Primary DI
- 03760125071213
- Version / Model
- Q-Link
- Company Name
- MANATEC
- Labeler DUNS
- 261064453
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 99a537d1-e43d-495c-86c6-260e45d9f743
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| DSB | Plethysmograph, Impedance | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12103 | Impedance cardiograph | A device that records the variations in thoracic electrical impedance caused by the activity of the heart muscle, usually detected at the body surface. A current is passed through the body and the product of this current and the body impedance is the electrical potential difference between two sensing electrodes. The graphic representation of the variation of the impedance with time is recorded in a diagram (impedance cardiogram). It is used to study the action of the heart muscle, for diagnosis of specific cardiac abnormalities, and to reveal trends or changes in heart function, especially cardiac output. Some types may include additional measurements (e.g., pulse oximetry, blood pressure). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760125071213 | GS1 |
Customer Contacts
- Phone
- +33372825000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140102 | 000 |