FDA UDI
In Commercial Distribution
🇺🇸 United States
ZOOM Aspiration Pump
DI: 04719876940087
·
Model: AFT117B
·
Taiwan Biomaterial Company Limited
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZOOM Aspiration Pump
- Primary DI
- 04719876940087
- Version / Model
- AFT117B
- Company Name
- Taiwan Biomaterial Company Limited
- Labeler DUNS
- 656073408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-17
- Public Version
- 2
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- cc13e0fa-8da6-4da4-8271-9a922e7191dc
Device Description
ZOOM POD Aspiration Tubing, AFT117B
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
- Yes
- 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 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47890 | Disposable surgical irrigation/aspiration system | A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719876940087 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place at room temperature.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.