FDA UDI
In Commercial Distribution
🇺🇸 United States
BR Surgical, LLC
DI: 00840183515522
·
Model: BR22-20000
·
BR Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
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
- BR Surgical, LLC
- Primary DI
- 00840183515522
- Version / Model
- BR22-20000
- Catalog Number
- BR22-20000
- Company Name
- BR Surgical, LLC
- Labeler DUNS
- 134781207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-10
- Public Version
- 1
- Public Version Date
- 2024-06-18
- Public Version Status
- New
- Public Device Record Key
- f8a3c2f2-dae6-4f55-9973-8002030e7dbd
Device Description
HEPARIN flushing needle, olive tip, Ø 3mm x 48mm (2")
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64113 | Vascular irrigation cannula, peripheral | A sterile, rigid tube designed to be surgically inserted, temporarily, into a peripheral blood vessel to function as a channel for the transport of irrigation fluid (e.g., saline, heparin solution) during open vascular surgery. It is typically made of metal with a shaped/bulbous tip (e.g., cone-, olive-shaped) and may be intended to be bent into shape; as it is a rigid device it is not intended to be advanced more than a minimal distance within the lumen of the blood vessel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840183515522 | GS1 |
Customer Contacts
- Phone
- 1-904-642-1366
- [email protected]