FDA UDI
In Commercial Distribution
🇺🇸 United States
ACIST Navvus® Catheter
DI: 10841716101240
·
Model: 014667
·
ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- ACIST Navvus® Catheter
- Primary DI
- 10841716101240
- Version / Model
- 014667
- Company Name
- ACIST MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 926684994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-15
- Public Version
- 6
- Public Version Date
- 2019-10-18
- Public Version Status
- Update
- Public Device Record Key
- bdff929e-603d-4848-ac25-7806fd52cd62
Device Description
Navvus Catheter, p/n 701481-010
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | 870.2870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15071 | Catheter-tip transducer, pressure | A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30841716101244 | GS1 | Shelf box | 1 | In Commercial Distribution | |
| Package | 20841716101247 | GS1 | Inner box | 5 | In Commercial Distribution | |
| Primary | 10841716101240 | GS1 | ||||
| Package | 30841716102340 | GS1 | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132474 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Working Length: 150 Centimeter |