Map-iT
- Primary DI
- 00818083016340
- Brand
- Map-iT
- Company
- ACCESS POINT TECHNOLOGIES, INC.
- Model
- 903709
- Catalog number
- 903709
- Device description
- STR, 4 electrode, MPD-CS-L, 2-8-2mm electrode spacing
- Published
- 2018-11-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00818083016340 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00818083016340 | 00818083016340 | 818083016340 | 0818083016340 |
GMDN Terms
| Term | Definition |
|---|---|
| Catheter-tip electrode | An electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signals from the electrode can help the operator determine the presence of left-to-right heart shunt. The electrical conductor may also be used to characterize the electrical activity of the heart. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 5 | French |
| Length | 110 | Centimeter |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 128599565
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00818083014001 | Map-iT | 903307 | 903307 | 2019-06-25 |
| 00818083015909 | Map-iT | 903602 | 903602 | 2019-06-25 |
| 00818083015947 | Map-iT | 903606 | 903606 | 2019-06-25 |
| 00818083015954 | Map-iT | 903607 | 903607 | 2019-06-25 |
| 00818083015961 | Map-iT | 903608 | 903608 | 2019-06-25 |
| 00818083015978 | Map-iT | 903609 | 903609 | 2019-06-25 |
| 00818083015985 | Map-iT | 903610 | 903610 | 2019-06-25 |
| 00818083016005 | Map-iT | 903612 | 903612 | 2019-06-25 |
| 00818083016036 | Map-iT | 903615 | 903615 | 2019-06-25 |
| 00818083016050 | Map-iT | 903617 | 903617 | 2019-06-25 |
| 00818083016067 | Map-iT | 903618 | 903618 | 2019-06-25 |
| 00818083016074 | Map-iT | 903619 | 903619 | 2019-06-25 |
| 00818083016081 | Map-iT | 903620 | 903620 | 2019-06-25 |
| 00818083016258 | Map-iT | 903700 | 903700 | 2019-06-25 |
| 00818083016265 | Map-iT | 903701 | 903701 | 2019-06-25 |
| 00818083016296 | Map-iT | 903704 | 903704 | 2019-06-25 |
| 00818083016302 | Map-iT | 903705 | 903705 | 2019-06-25 |
| 00818083016319 | Map-iT | 903706 | 903706 | 2019-06-25 |
| 00818083016326 | Map-iT | 903707 | 903707 | 2019-06-25 |
| 00818083016685 | Map-iT | 903732 | 903732 | 2019-06-25 |
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| 00763000719289 | NA | MEDTRONIC, INC. | DRF | 2024-08-22 |
| 00763000719296 | NA | MEDTRONIC, INC. | DRF | 2024-08-22 |
| 00763000719302 | NA | MEDTRONIC, INC. | DRF | 2024-08-22 |
| 00763000443214 | NA | MEDTRONIC, INC. | DRF | 2024-05-18 |
| 00763000465728 | NA | MEDTRONIC, INC. | DRF | 2024-05-18 |
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