FDA UDI
In Commercial Distribution
🇺🇸 United States
FlowMet™
DI: 00860001276114
·
Model: FMET-IM-SENS-5
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FlowMet™
- Primary DI
- 00860001276114
- Version / Model
- FMET-IM-SENS-5
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 1
- Public Version Date
- 2021-07-26
- Public Version Status
- New
- Public Device Record Key
- 4f5b7a14-de7a-4aca-8927-520f29f57d10
Device Description
SENSOR FMET-IM-SENS-5
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
- No
- 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 |
|---|---|---|---|---|
| DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65421 | Laser speckle blood flowmeter | An electrically-powered device designed to use laser speckle imaging to measure micro- and macrovascular blood circulation and to assess the extent of vascular flow and associated changes [i.e., due to clots, stenosis, vascular tone changes, mechanical damage, and peripheral vascular disease (PVD)]. It uses laser light projected onto tissue and a multi-element light detector (e.g., a digital camera) to detect remitted light, thus enabling a measure of spatial variation (map) of blood flow. The device typically consists of one or more optical sensors connected to a software-controlled control/visual display unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860001276111 | GS1 | PK | 5 | In Commercial Distribution | |
| Primary | 00860001276114 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192966 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature transport 32°F to 122°F (0°C to 50°C)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Relative humidity storage 50% noncondensing
- Type
- Special Storage Condition, Specify
- Special Conditions
- Relative humidity transport 20% to 80% noncondensing
- Type
- Special Storage Condition, Specify
- Special Conditions
- Altitude (storage and transport) -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature storage 73°F (23°C)