FDA UDI
In Commercial Distribution
🇺🇸 United States
NES Reprocessed Visions PV .035 Digital IVUS Catheter
DI: 00850044399130
·
Model: R-88901
·
NORTH EAST SCIENTIFIC INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NES Reprocessed Visions PV .035 Digital IVUS Catheter
- Primary DI
- 00850044399130
- Version / Model
- R-88901
- Catalog Number
- R-88901
- Company Name
- NORTH EAST SCIENTIFIC INC
- Labeler DUNS
- 608625823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-21
- Public Version
- 1
- Public Version Date
- 2025-05-29
- Public Version Status
- New
- Public Device Record Key
- 2dcc08c9-3cca-4ec2-85a0-0e86d614470c
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64174 | Intravascular ultrasound imaging catheter, reprocessed | A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850044399130 | GS1 | ||||
| Previous | B227R889010 | HIBCC |
Customer Contacts
- Phone
- 203-756-2111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181126 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 90 | Centimeter | |
| Lumen/Inner Diameter | 0.035 | Inch | |
| Introducer Sheath Compatibility | 8.5 | French |