FDA UDI
In Commercial Distribution
🇺🇸 United States
Ulti-Flo General Purpose Drainage Catheter
DI: 00817640020486
·
Model: LBL2T-1430HB
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Ulti-Flo General Purpose Drainage Catheter
- Primary DI
- 00817640020486
- Version / Model
- LBL2T-1430HB
- Catalog Number
- LBL2T-1430HB
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-27
- Public Version
- 1
- Public Version Date
- 2022-05-05
- Public Version Status
- New
- Public Device Record Key
- f51ea44b-93ae-4941-ac5e-64a522da0233
Device Description
HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F
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
- 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 |
|---|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817640020483 | GS1 | Dispenser | 5 | In Commercial Distribution | |
| Primary | 00817640020486 | GS1 | ||||
| Package | 20817640020480 | GS1 | Shipper | 4 | In Commercial Distribution | |
| Previous | H862LBL2T1430HB0 | HIBCC |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 14 | French | |
| Length | 19 | Centimeter |