FDA UDI
In Commercial Distribution
🇺🇸 United States
ZOOM™ Duoport Canister
DI: 04719876940186
·
Model: TDC001B
·
Taiwan Biomaterial Company Limited
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZOOM™ Duoport Canister
- Primary DI
- 04719876940186
- Version / Model
- TDC001B
- Company Name
- Taiwan Biomaterial Company Limited
- Labeler DUNS
- 656073408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-24
- Public Version
- 1
- Public Version Date
- 2025-03-04
- Public Version Status
- New
- Public Device Record Key
- 16db3e95-ecb0-4865-b0c0-efa6580abe0d
Device Description
An accessories of Zoom Asipration Pump. Commercial prodcut name (Brand name): ZOOM™ Duoport Canister Model number: TDC001B
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34858 | Surgical suction system collection container, single-use | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device. | No | Active |
| 65275 | Thrombectomy electric suction pump, reusable | An electrically-powered pump designed specifically to aspirate clotted blood (e.g., thrombi, emboli), or other formed elements, from vessels of the arterial and venous systems to treat vascular obstruction and restore blood flow. It generates a negative pressure for aspiration and may be provided with collection containers, syringe and tubing; it is typically intended to be connected to a patient contact catheter (not included). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719876940186 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190105 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight. Store at room temperature.