FDA UDI
In Commercial Distribution
🇺🇸 United States
Primi™ Support Catheter
DI: M781P351201701
·
Model: P35-120-170
·
Thermopeutix, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Primi™ Support Catheter
- Primary DI
- M781P351201701
- Version / Model
- P35-120-170
- Company Name
- Thermopeutix, Inc.
- Labeler DUNS
- 138648154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 6
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 471f6378-741d-44f1-a04d-89f187a595b2
Device Description
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
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
- 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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32151 | Peripheral vascular intervention infusion catheter | A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M781P351201701 | HIBCC |
Customer Contacts
- Phone
- 1-858-549-1760
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130850 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Sheath Compatibility: 6 Fr | ||
| Device Size Text, specify | Shaft Length: 170 cm | ||
| Device Size Text, specify | Tracking Length: 120 mm | ||
| Device Size Text, specify | Guide Wire Compatibility: 0.035” |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 55 Degrees Celsius