FDA UDI
In Commercial Distribution
🇺🇸 United States
SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg
DI: 05391530750035
·
Model: SVDS200
·
DMC MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg
- Primary DI
- 05391530750035
- Version / Model
- SVDS200
- Catalog Number
- FD-1003
- Company Name
- DMC MEDICAL LIMITED
- Labeler DUNS
- 989772017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 506dfd9e-d6aa-45c1-b748-55165a5ab84d
Device Description
Saphenous Vein Distention System - 200mmHg - Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44552 | Vein irrigation/distention set | A collection of devices used for the distention and irrigation of veins (e.g., saphenous) for testing and clearance prior to removal of a section for use as a coronary or peripheral bypass graft. It is also used for vein distention to facilitate ligating side branches in the vein. It typically consists of a standard syringe (e.g., 60 ml), various stainless steel devices (pin, spring, rod), and plastic rings and balls that are used during the process. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391530750059 | GS1 | 3 | In Commercial Distribution | ||
| Package | 05391530750042 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 05391530750035 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000704 | 000 |