Meritrans®
13 catalogue numbers from 00884450240434, listed by Merit Medical Systems, Inc., United States, under Cardiovascular Procedure Kit. 1 manufacturer in China is registered for this product code.
1manufacturer
13catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-13 |
| Record revised | 2025-05-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 4, pack of 15, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450240434 | Cable Length-12″ (30.5 cm) | In distribution |
| 00884450048542 | Cable Length-12″ (30.5 cm) | In distribution |
| Initial Release | Cable Length-12″ (30.5 cm) | In distribution |
| 00884450240526 | Cable Length-48″ (122 cm) | In distribution |
| 00884450240489 | Cable Length-48″ (122 cm) | In distribution |
| 00884450240458 | Cable Length-12″ (30.5 cm) | In distribution |
| Initial Release | Cable Length-12″ (30.5 cm) | In distribution |
| 00884450240472 | Cable Length-48″ (122 cm) | In distribution |
| 00884450240496 | Cable Length-48″ (122 cm) | In distribution |
| 00884450240465 | Cable Length-12″ (30.5 cm) | In distribution |
| 00884450240441 | Cable Length-12″ (30.5 cm) | In distribution |
| 00884450240533 | Cable Length-48″ (122 cm) | In distribution |
| 00884450240502 | Cable Length-12″ (30.5 cm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Medline Industries, Inc. | Medline Industries, Inc. | 17,468 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| Halyard | Avid Medical, Inc. | 2,108 |
| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-12-04 | Class II | Process control | Inflation device handle may detach from the syringe during procedure. | 2192 units | |
| 2025-06-05 | Class II | Process control | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | 6327 | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 188837 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 168157 kits | |
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 69 kits | |
| 2009-01-29 | Not classified | Process control | A manufacturing defect may prevent adequate sterilization of the entire device. | 157 units | 2011-06-16 |
| 2009-01-29 | Not classified | Process control | A manufacturing defect may prevent adequate sterilization of the entire device. | 220 units | 2011-06-16 |
| 2009-01-29 | Not classified | Process control | A manufacturing defect may prevent adequate sterilization of the entire device. | 145 units | 2011-06-16 |
| 2009-01-29 | Not classified | Process control | A manufacturing defect may prevent adequate sterilization of the entire device. | 20 units | 2011-06-16 |
| 2009-01-29 | Not classified | Process control | A manufacturing defect may prevent adequate sterilization of the entire device. | 368 units | 2011-06-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.