Exodus
- Primary DI
- H965105721
- Brand
- Exodus
- Company
- NAVILYST MEDICAL, INC.
- Model
- 10572
- Device description
- Array Multipurpose Drainage Catheter 14F x 35cm with Standard Pigtail
- Published
- 2016-08-03
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
angiodynamics.comProduct 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 |
|---|---|
| K152069 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| H965105721 | Package | HIBCC | 5 | In Commercial Distribution |
| H965105720 | Primary | HIBCC | 0 | |
| 15051684022835 | Secondary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15051684022835 | 15051684022835 |
GMDN Terms#
| Term | Definition |
|---|---|
| Closed-wound drain | A sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 14 | French |
| Length | 35 | Centimeter |
| Outer Diameter | 4.7 | Millimeter |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(518)795-1676 | dgreer@angiodynamics.com |
Regulatory Flags#
- DUNS number
- 809699023
- 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 |
|---|---|---|---|---|
| H787LG191005 | Lifeguard | LG-19-100 | 2016-09-20 | |
| H787LG19755 | Lifeguard | LG-19-75 | 2016-09-20 | |
| H787LG201005 | Lifeguard | LG-20-100 | 2016-09-20 | |
| H787LG201505 | Lifeguard | LG-20-150 | 2016-09-20 | |
| H787LG20505 | Lifeguard | LG-20-50 | 2016-09-20 | |
| H787LG20755 | Lifeguard | LG-20-75 | 2016-09-20 | |
| H787LG221005 | Lifeguard | LG-22-100 | 2016-09-20 | |
| H787LG22505 | Lifeguard | LG-22-50 | 2016-09-20 | |
| H787LG22755 | Lifeguard | LG-22-75 | 2016-09-20 | |
| H787LPS30045 | Lifeport | LPS 3004 | 2016-09-20 | |
| H787LPS30055 | Lifeport | LPS 3005 | 2016-09-20 | |
| H787LPS30065 | Lifeport | LPS 3006 | 2016-09-20 | |
| H787LPS30075 | Lifeport | LPS 3007 | 2016-09-20 | |
| H787LPS30085 | Lifeport | LPS 3008 | 2016-09-20 | |
| H787LPS30095 | Lifeport | LPS 3009 | 2016-09-20 | |
| H787LPS30175 | Lifeport | LPS 3017 | 2016-09-20 | |
| H787LPS30235 | Lifeport | LPS 3023 | 2016-09-20 | |
| H787LPS30255 | Lifeport | LPS 3025 | 2016-09-20 | |
| H787CT50LPBANFVI0 | BioFlo Vortex | CT50LPBANFVI | 2020-05-29 | |
| H787CT50LPBAVI0 | BioFlo Vortex | CT50LPBAVI | 2020-05-29 |
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 |