FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartLight
DI: 00868976000147
·
Model: 18-3356
·
CARDIOFOCUS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartLight
- Primary DI
- 00868976000147
- Version / Model
- 18-3356
- Catalog Number
- 18-3356
- Company Name
- CARDIOFOCUS, INC.
- Labeler DUNS
- 068966261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-15
- Public Version
- 4
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 465bb933-2c31-42c4-9621-739e48b7c3d5
Device Description
Deflectable Sheath
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRA | CATHETER, STEERABLE | Cardiovascular | 870.1280 | 2 |
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36079 | Haemostasis valve | A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868976000147 | GS1 |
Customer Contacts
- Phone
- +1(844)527-3723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152310 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 75 | Centimeter | |
| Lumen/Inner Diameter | 4 | Millimeter |