FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE® Tri Lumen Catheter
DI: 00733132644421
·
Model: TLC140
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GORE® Tri Lumen Catheter
- Primary DI
- 00733132644421
- Version / Model
- TLC140
- Catalog Number
- TLC140
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-29
- Public Version
- 1
- Public Version Date
- 2024-03-08
- Public Version Status
- New
- Public Device Record Key
- a13d0323-2920-4acc-9b4e-9e4221f7b1ba
Device Description
140CM TRI-LUMEN CATHETER
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132644421 | GS1 |
Customer Contacts
- Phone
- +1(800)528-8763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180919 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 12 | French | |
| Catheter Working Length | 140 | Centimeter | |
| Length | 1400 | Millimeter |