FDA UDI
In Commercial Distribution
🇺🇸 United States
FreedomFlow Orbital Circumferential Atherectomy System
DI: 00850040691030
·
Model: H6001
·
Cardio Flow, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FreedomFlow Orbital Circumferential Atherectomy System
- Primary DI
- 00850040691030
- Version / Model
- H6001
- Company Name
- Cardio Flow, Inc.
- Labeler DUNS
- 080505958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-21
- Public Version
- 1
- Public Version Date
- 2024-07-01
- Public Version Status
- New
- Public Device Record Key
- 327f18ad-4b87-4df7-84c1-b52b14502038
Device Description
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 5-sphere
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
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | 870.4875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44307 | Mechanical atherectomy system catheter, peripheral | A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850040691030 | GS1 | ||||
| Package | 90850040691040 | GS1 | Case | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-294-5517
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231538 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Atherectomy Rotating Component Diameter | 1.5 | Millimeter |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 50 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 50 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius