HeartSpan®
- Primary DI
- 00884450163764
- Brand
- HeartSpan®
- Company
- Merit Medical
- Model
- 00884450163764
- Published
- 2017-03-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| DRC | Trocar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DRC | Trocar | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00884450163764 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00884450163764 | 00884450163764 | 884450163764 | 0884450163764 |
GMDN Terms
| Term | Definition |
|---|---|
| Cardiac transseptal needle | A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 065673912
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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 |
|---|---|---|---|---|
| 00884450313763 | Prelude Prestige™ | 10884450313760 | PLPS-2510 | 2020-06-02 |
| 00884450313794 | Prelude Prestige™ | 10884450313791 | PLPS-2508 | 2020-06-02 |
| 00884450495568 | Hydrophilic Prelude SNAP™ | 10884450495565 | PLSH-1009.5/A | 2021-11-22 |
| 00884450313732 | Prelude Prestige™ | 10884450313739 | PLPS-1008 | 2021-04-09 |
| 00884450313800 | Prelude Prestige™ | 10884450313807 | PLPS-1010 | 2021-04-09 |
| 00884450313831 | Prelude Prestige™ | 10884450313838 | PLPS-1011 | 2021-04-09 |
| 00884450313855 | Prelude Prestige™ | 10884450313852 | PLPS-1012 | 2021-04-09 |
| 00884450451410 | HeartSpan® | 00884450451410 | FND-019-03/A | 2020-12-24 |
| 00884450451663 | HeartSpan® | 00884450451663 | FND-020-01/A | 2020-12-08 |
| 10884450313661 | Prelude Prestige™ | 10884450313661 | PLPS-1006 | 2019-07-05 |
| 10884450313685 | Prelude Prestige™ | 10884450313685 | PLPS-1007 | 2019-07-05 |
| 10884450313692 | Prelude Prestige™ | 10884450313692 | PLPS-2514 | 2019-07-29 |
| 10884450313722 | Prelude Prestige™ | 10884450313722 | PLPS-2512 | 2019-07-29 |
| 10884450313753 | Prelude Prestige™ | 10884450313753 | PLPS-1009 | 2019-07-29 |
| 10884450313784 | Prelude Prestige™ | 10884450313784 | PLPS-2509 | 2019-07-29 |
| 10884450313913 | Prelude Prestige™ | 10884450313913 | PLPS-1014 | 2019-08-14 |
| 10884450451677 | HeartSpan® | 00884450451670 | FND-020-02/A | 2020-09-11 |
| 10884450451691 | HeartSpan® | 00884450451694 | FND-020-05/A | 2020-09-08 |
| 10884450451707 | HeartSpan® | 00884450451700 | FND-020-06/A | 2020-09-04 |
| 10884450451653 | HeartSpan® | 00884450451656 | FND-019-06/A | 2020-08-13 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00888867500914 | Arthrex® | ARTHREX, INC. | DRC | 2026-03-13 |
| 04262494463594 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463631 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463785 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463792 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463808 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463815 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463822 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463839 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494463846 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-09-12 |
| 04262494461064 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-05 |
| 04262494461224 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-05 |
| 04262494461019 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461026 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461033 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461040 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461057 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461071 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461088 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461095 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461101 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461118 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461125 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461132 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461149 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461156 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461163 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461170 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461187 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |
| 04262494461194 | N/A | Doppkon GmbH & Co. KG | DRC | 2025-08-04 |