FDA UDI
In Commercial Distribution
🇺🇸 United States
LiquID 051 LP
DI: 00850012180043
·
Model: 6F LP
·
Seigla Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LiquID 051 LP
- Primary DI
- 00850012180043
- Version / Model
- 6F LP
- Catalog Number
- M3000
- Company Name
- Seigla Medical, Inc.
- Labeler DUNS
- 035365243
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-05
- Public Version
- 2
- Public Version Date
- 2025-11-11
- Public Version Status
- Update
- Public Device Record Key
- f4c8a768-cee2-46cf-bb0b-44b6df306f20
Device Description
Guide Catheter Extension
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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64885 | Vascular guide-catheter extension | A flexible tube designed to extend the length of a vascular guide-catheter during percutaneous transluminal passage and placement of a diagnostic/interventional device (e.g., pacing lead, balloon dilatation catheter) within either the coronary or peripheral vasculature. It is intended to be inserted through the lumen of the guide-catheter, and includes a proximal handle and delivery shaft connected to a distal catheter-extending tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012180043 | GS1 |
Customer Contacts
- Phone
- 7632035428
- [email protected]
- Phone
- 6125818703
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243691 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6 | French |