FDA UDI
In Commercial Distribution
🇺🇸 United States
PF 6010 LDPM/Temp Unit
DI: 07332834000110
·
Model: PF 6010
·
Perimed AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PF 6010 LDPM/Temp Unit
- Primary DI
- 07332834000110
- Version / Model
- PF 6010
- Company Name
- Perimed AB
- Labeler DUNS
- 354765570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7a4cc065-e147-405c-ae12-12df24a03ac3
Device Description
PF 6010 LDPM/Temp Unit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60451 | Laser Doppler blood flowmeter | A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/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 |
|---|---|---|---|---|---|---|
| Primary | 07332834000110 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152930 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 110 KiloPascal