FDA UDI
In Commercial Distribution
🇺🇸 United States
LEFT HEART SUMP - 45 DEGREE
DI: B0662010440000
·
Model: 201044-000
·
NOVOSCI CORP.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- LEFT HEART SUMP - 45 DEGREE
- Primary DI
- B0662010440000
- Version / Model
- 201044-000
- Catalog Number
- 201044-000
- Company Name
- NOVOSCI CORP.
- Labeler DUNS
- 938289980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-14
- Public Version
- 6
- Public Version Date
- 2023-06-20
- Public Version Status
- Update
- Public Device Record Key
- fc6868bb-f11d-4276-b03d-6cc9a90fdfba
Device Description
A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.
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
- No
- 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 |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 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 |
|---|---|---|---|---|---|---|
| Package | B0662010440006 | HIBCC | Case | 100 | In Commercial Distribution | |
| Primary | B0662010440000 | HIBCC | ||||
| Package | B0662010440005 | HIBCC | Partial Case | 75 | In Commercial Distribution | |
| Package | B0662010440004 | HIBCC | Partial Case | 50 | In Commercial Distribution | |
| Package | B0662010440003 | HIBCC | Inner Carton | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-854-0567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K801392 | 000 |