FDA UDI
In Commercial Distribution
🇺🇸 United States
Nit-Occlud PDA
DI: 04042301160010
·
Model: 145096V2
·
pfm medical ag
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nit-Occlud PDA
- Primary DI
- 04042301160010
- Version / Model
- 145096V2
- Catalog Number
- 145096V2
- Company Name
- pfm medical ag
- Labeler DUNS
- 316661214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-06
- Public Version
- 6
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- d4078ab1-515f-404f-8994-52deaa6ed55b
Device Description
Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MAE | Occluder, Patent Ductus, Arteriosus | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45418 | Cardiac defect occluder | An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 4042301160027 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04042301160010 | GS1 |
Customer Contacts
- Phone
- 7607588749
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120009 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9 x 6 |