FDA UDI
In Commercial Distribution
🇺🇸 United States
LF
DI: 10746190002086
·
Model: 601280
·
Liebel-Flarsheim Company LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LF
- Primary DI
- 10746190002086
- Version / Model
- 601280
- Company Name
- Liebel-Flarsheim Company LLC
- Labeler DUNS
- 080186051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-03
- Public Version
- 4
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 6db7ae24-6e3e-4fce-8cbb-9f26e8addd38
Device Description
Tubing with Male Luer Adapter (High Pressure)
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 |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44685 | Radiographic procedure tubing | A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20746190002083 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 10746190002086 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K882329 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 6895 | KiloPascal | |
| Pressure | 1000 | Pound per Square Inch | |
| Length | 76 | Centimeter | |
| Length | 30 | Inch |