FDA UDI
In Commercial Distribution
🇺🇸 United States
DVT-SERIES
DI: 08809315675741
·
Model: DS211
·
DAESUNG MAREF CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- DVT-SERIES
- Primary DI
- 08809315675741
- Version / Model
- DS211
- Company Name
- DAESUNG MAREF CO.,LTD.
- Labeler DUNS
- 688817949
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-22
- Public Version
- 1
- Public Version Date
- 2021-06-30
- Public Version Status
- New
- Public Device Record Key
- d7699f44-c352-41e0-8a8c-43e1a1fd1cb2
Device Description
SOFT THIGH SLEEVE, Small 2ea, [One ploybag]
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
- Yes
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 | 18809315675748 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 08809315675741 | GS1 | ||||
| Package | 28809315675745 | GS1 | Box | 20 | In Commercial Distribution | |
| Package | 38809315675742 | GS1 | Box | 40 | In Commercial Distribution |