FDA UDI
In Commercial Distribution
🇺🇸 United States
MediMaxTech Inc.
DI: 00817325026574
·
Model: MSH22M
·
MEDIMAX TECH INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MediMaxTech Inc.
- Primary DI
- 00817325026574
- Version / Model
- MSH22M
- Company Name
- MEDIMAX TECH INC.
- Labeler DUNS
- 927071162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-25
- Public Version
- 2
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- c8baac5a-e8a5-429a-a291-b451bc8a2425
Device Description
Smoke Evacuation Tubing 22mm (7/8 in) Tubing x 10 ft hose, Sterile
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
- Yes
- 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 |
|---|---|---|---|---|
| GAZ | Tubing, Noninvasive | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46483 | Surgical plume evacuation system tube | A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817325026571 | GS1 | Box | 24 | In Commercial Distribution | |
| Primary | 00817325026574 | GS1 |
Customer Contacts
- Phone
- 8556334629
- [email protected]