FDA UDI
In Commercial Distribution
🇺🇸 United States
VasoPress
DI: 00815245010338
·
Model: VP501M
·
COMPRESSION THERAPY CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- VasoPress
- Primary DI
- 00815245010338
- Version / Model
- VP501M
- Company Name
- COMPRESSION THERAPY CONCEPTS, INC.
- Labeler DUNS
- 788065217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-09
- Public Version
- 4
- Public Version Date
- 2018-10-23
- Public Version Status
- Update
- Public Device Record Key
- 664131f9-35e1-4094-96b1-a736d37b1f1f
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 |
|---|---|---|---|---|
| 44769 | Single-chamber venous compression system garment, single-use | An 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 intermittent inflation of a single-chamber. 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 | 40815245010374 | GS1 | 2880 | In Commercial Distribution | ||
| Primary | 00815245010338 | GS1 | ||||
| Package | 30815245010360 | GS1 | 80 | In Commercial Distribution | ||
| Package | 20815245010356 | GS1 | 20 | In Commercial Distribution | ||
| Package | 10815245010342 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 7325440800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000147 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 18 | Inch |