ALIMAXX-B®
- Primary DI
- 10884450031091
- Brand
- ALIMAXX-B®
- Company
- Merit Medical Systems, Inc.
- Model
- 00884450031094
- Catalog number
- 70129-209/C
- Published
- 2016-09-20
- 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 |
|---|---|
| K093947 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10884450031091 | Package | GS1 | 1 | In Commercial Distribution |
| 00884450031094 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10884450031091 | 10884450031091 | ||
| 00884450031094 | 00884450031094 | 884450031094 | 0884450031094 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bare-metal biliary stent | A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| 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 |