Single Use Nasal Biliary Drainage Tube V
- Primary DI
- 04953170309519
- Brand
- Single Use Nasal Biliary Drainage Tube V
- Company
- OLYMPUS MEDICAL SYSTEMS CORP.
- Model
- PBD-V813W-06
- Published
- 2016-09-21
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
xx.xxProduct 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 |
|---|---|
| K944912 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 14953170309516 | Package | GS1 | 1 | Not in Commercial Distribution |
| 04953170309519 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 14953170309516 | 14953170309516 | |
| 04953170309519 | 04953170309519 | 4953170309519 |
GMDN Terms#
| Term | Definition |
|---|---|
| Nasal biliary/pancreatic drainage catheter | A sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or pancreatic tract via the sphincter of Oddi, and terminate proximally via the nasal passage; devices associated with catheter introduction/connection (excluding the endoscope) may be included (e.g., nasal transfer tube, drainage connecting tube, guidewire), however it does not include any fluid collection bags/containers. This is a single-use device. |
Contacts#
| Phone | |
|---|---|
| +1(800)401-1086 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 711789789
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04953170158759 | DISPOSABLE HOT BIOPSY FORCEPS | FD-210U | 2016-09-21 | |
| 04953170158766 | DISPOSABLE HOT BIOPSY FORCEPS | FD-230U | 2016-09-21 | |
| 04953170354236 | DISPOSABLE HOT BIOPSY FORCEPS | FD-210U | N5356530 | 2016-09-21 |
| 04953170354243 | DISPOSABLE HOT BIOPSY FORCEPS | FD-230U | N5356630 | 2016-09-21 |
| 04953170214288 | RECORDER UNIT HARNESS | MAJ-1475 | N2483830 | 2023-06-21 |
| 04953170331718 | Light guide | OCS5-LG | 2016-09-21 | |
| 04953170333316 | RECORDER HOLDER | MAJ-2033 | N4472030 | 2016-09-21 |
| 04953170467592 | DISPOSABLE BIOPSY FORCEPS | FB-211D | N5431842 | 2026-04-09 |
| 04953170467608 | DISPOSABLE BIOPSY FORCEPS | FB-221D | N5431942 | 2026-04-09 |
| 04953170467615 | DISPOSABLE BIOPSY FORCEPS | FB-231D | N5432042 | 2026-04-09 |
| 04953170467622 | DISPOSABLE BIOPSY FORCEPS | FB-241D | N5432142 | 2026-04-09 |
| 04953170466038 | Single Use Electrosurgical Hemostatic Forceps | FD-410LR | N1086141 | 2026-04-01 |
| 04953170466182 | Single Use Electrosurgical Hemostatic Forceps | FD-411UR | N3046340 | 2026-04-01 |
| 04953170466267 | Single Use Electrosurgical Hemostatic Forceps | FD-412LR | N5368640 | 2026-04-01 |
| 04953170035647 | ELECTROSURGICAL SNARE | SD-5L-1 | 2016-09-21 | |
| 04953170035708 | ELECTROSURGICAL SNARE | SD-5U-1 | 2016-09-21 | |
| 04953170035838 | ELECTROSURGICAL SNARE | SD-6U-1 | 2016-09-21 | |
| 04953170035951 | ELECTROSURGICAL SNARE | SD-7P-1 | 2016-09-21 | |
| 04953170035968 | ELECTROSURGICAL SNARE | SD-7P-1 | 2016-09-21 | |
| 04953170036033 | ELECTROSURGICAL SNARE | SD-8P-1 | 2016-09-21 |
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