FDA UDI
In Commercial Distribution
🇺🇸 United States
VacuumCushion 100x85CPC
DI: 08719425705224
·
Model: VC10085
·
MACROMEDICS B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VacuumCushion 100x85CPC
- Primary DI
- 08719425705224
- Version / Model
- VC10085
- Catalog Number
- 155610
- Company Name
- MACROMEDICS B.V.
- Labeler DUNS
- 489730120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 621ea2d2-1dfa-439f-8b7c-de9c660bf8c9
Device Description
Vacuum Cushion, 100x85 cm, 45L Fill, Dark Blue, CPC valve
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40895 | Vacuum-mould patient positioning system | An assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719425705224 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142420 | 000 |