FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FilterFlow
DI: 00768455145690
·
Model: 33094182
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- FilterFlow
- Primary DI
- 00768455145690
- Version / Model
- 33094182
- Catalog Number
- 33094182
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2022-05-23
- Public Version Status
- Update
- Public Device Record Key
- d2597f6a-3297-4da9-89fc-f2f612ea5e33
- Distribution End Date
- 2022-05-20
Device Description
UNO_33094182 FilterFlow handle W/O tube
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
- 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 |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63649 | General-purpose surgical suction system, vacuum | An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00768455145690 | GS1 | ||||
| Package | 05705243311795 | GS1 | Carton | 20 | Not in Commercial Distribution | 2022-05-20 |
| Package | 05705243311801 | GS1 | Case | 2 | Not in Commercial Distribution | 2022-05-20 |
Customer Contacts
- Phone
- 1-800-422-8811
- [email protected]