ReSolve®
- Primary DI
- 10884450313302
- Brand
- ReSolve®
- Company
- Merit Medical Systems, Inc.
- Model
- 00884450313305
- Catalog number
- RBDC-8-038/C
- Published
- 2017-10-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K141408 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10884450313302 | Package | GS1 | 5 | In Commercial Distribution |
| 00884450313305 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10884450313302 | 10884450313302 | ||
| 00884450313305 | 00884450313305 | 884450313305 | 0884450313305 |
GMDN Terms#
| Term | Definition |
|---|---|
| Biliary drainage catheter | A flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. 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 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 184763290
- 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
- false
- 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 |
|---|---|---|---|---|
| 00884450031131 | Merit Medical® | Initial Release | K08-02653A | 2026-05-28 |
| 00884450392850 | SCOUT MD™ | Initial Release | MDS05A-01 | 2026-05-28 |
| 00884450392867 | SCOUT MD™ | Initial Release | MDS05B-01 | 2026-05-28 |
| 00884450392874 | SCOUT MD™ | Initial Release | MDS05C-01 | 2026-05-28 |
| 00884450392881 | SCOUT MD™ | Initial Release | MDS05M-01 | 2026-05-28 |
| 00884450392935 | SCOUT MD™ | Initial Release | MDS75A-01 | 2026-05-28 |
| 00884450392942 | SCOUT MD™ | Initial Release | MDS75B-01 | 2026-05-28 |
| 00884450392959 | SCOUT MD™ | Initial Release | MDS75C-01 | 2026-05-28 |
| 00884450392966 | SCOUT MD™ | Initial Release | MDS75M-01 | 2026-05-28 |
| 00884450428313 | Merit Medical® | Initial Release | K09-09671B | 2026-05-28 |
| 00884450430057 | Merit Medical® | Initial Release | K12-01244B | 2026-05-28 |
| 00884450487532 | Merit Medical® | Initial Release | K09T-13647 | 2026-05-28 |
| 00884450487549 | Merit Medical® | Initial Release | K12T-11710A | 2026-05-28 |
| 00884450487679 | Merit Medical® | Initial Release | K10T-06195A | 2026-05-28 |
| 00884450766958 | Performa® | B | 1623-F820M | 2026-05-28 |
| 10884450415358 | Prelude® | J | PSI-4F-23MT | 2026-05-28 |
| 00884450392898 | SCOUT MD™ | Initial Release | MDS10A-01 | 2026-05-23 |
| 00884450392904 | SCOUT MD™ | Initial Release | MDS10B-01 | 2026-05-23 |
| 00884450392911 | SCOUT MD™ | Initial Release | MDS10C-01 | 2026-05-23 |
| 00884450393383 | SCOUT MD™ | Initial Release | MDS75SA-01 | 2026-05-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 15711055100400 | M-Drain | Mermaid Medical A/S | FGE | 2024-10-01 |
| 15711055110041 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055110409 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055120040 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055120453 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055000311 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000328 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000359 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000373 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000410 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000434 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000458 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000472 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000496 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000519 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000533 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000557 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000588 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000595 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000625 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000632 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000663 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000670 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000700 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000724 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000748 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000762 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000779 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000809 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000816 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |