FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LF
DI: 10746190002338
·
Model: 900101
·
Liebel-Flarsheim Company LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LF
- Primary DI
- 10746190002338
- Version / Model
- 900101
- Company Name
- Liebel-Flarsheim Company LLC
- Labeler DUNS
- 080186051
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 6
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 31ff7442-5590-467e-bc02-4d3baa682b7e
- Distribution End Date
- 2018-06-04
Device Description
Angio Syringe with Handi-Fil Straw; fits injector: Angiomat Illumena
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 |
|---|---|---|---|---|
| 15286 | Angiographic syringe | A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20746190002335 | GS1 | Case | 50 | Not in Commercial Distribution | 2018-06-04 |
| Primary | 10746190002338 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963071 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 150 | Milliliter |