FDA UDI
In Commercial Distribution
🇺🇸 United States
VasoGrad
DI: 00815245011977
·
Model: VG530LR
·
COMPRESSION THERAPY CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- VasoGrad
- Primary DI
- 00815245011977
- Version / Model
- VG530LR
- Company Name
- COMPRESSION THERAPY CONCEPTS, INC.
- Labeler DUNS
- 788065217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-10-23
- Public Version Status
- Update
- Public Device Record Key
- a4b58857-dce2-4e1a-a05b-0b3a851ff05d
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
- No
- 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 |
|---|---|---|---|---|
| 44762 | Multi-chamber venous compression system garment, single-use | A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40815245012019 | GS1 | 1440 | In Commercial Distribution | ||
| Primary | 00815245011977 | GS1 | ||||
| Package | 30815245012005 | GS1 | 40 | In Commercial Distribution | ||
| Package | 20815245011995 | GS1 | 20 | In Commercial Distribution | ||
| Package | 10815245011981 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 7325440800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 36 | Inch |