FDA UDI
In Commercial Distribution
🇺🇸 United States
blue endo
DI: 04714127863184
·
Model: 70-7050F1
·
UNIMAX MEDICAL SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- blue endo
- Primary DI
- 04714127863184
- Version / Model
- 70-7050F1
- Company Name
- UNIMAX MEDICAL SYSTEMS INC.
- Labeler DUNS
- 658122465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-20
- Public Version
- 1
- Public Version Date
- 2024-06-28
- Public Version Status
- New
- Public Device Record Key
- 1f4ff6f0-91af-4292-9a1e-d5cb75b4a15c
Device Description
Smoke evacuation tubing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCZ | Tube, Smoke Removal, Endoscopic | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60836 | Laparoscopic plume filter | A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14714127863181 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04714127863184 | GS1 | ||||
| Package | 24714127863188 | GS1 | Carton | 6 | In Commercial Distribution |