FDA UDI
In Commercial Distribution
🇺🇸 United States
The Venous Assist System(DVT-2600)
DI: 08809315678797
·
Model: DS121
·
DAESUNG MAREF CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
2
Basic Information
- Brand Name
- The Venous Assist System(DVT-2600)
- Primary DI
- 08809315678797
- Version / Model
- DS121
- Company Name
- DAESUNG MAREF CO.,LTD.
- Labeler DUNS
- 688817949
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-10-18
- Public Version
- 5
- Public Version Date
- 2021-06-30
- Public Version Status
- Update
- Public Device Record Key
- 3ffbc9b8-ee04-4202-a65d-b0c22ff78c94
Device Description
3chamber oxford calf garment (One size)
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44768 | Multi-chamber venous compression system garment, reusable | An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38809315678798 | GS1 | BOX | 4 | Not in Commercial Distribution | 2021-06-30 |
| Package | 18809315678794 | GS1 | BOX | 10 | Not in Commercial Distribution | 2021-06-30 |
| Primary | 08809315678797 | GS1 | ||||
| Package | 28809315678791 | GS1 | BOX | 2 | Not in Commercial Distribution | 2021-06-30 |
| Unit of Use | 08809315678780 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112677 | 000 |