FDA UDI
In Commercial Distribution
🇺🇸 United States
EASYMIX® vacuum pump I
DI: 04260056881633
·
Model: 02-0401
·
OSARTIS GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EASYMIX® vacuum pump I
- Primary DI
- 04260056881633
- Version / Model
- 02-0401
- Catalog Number
- 02-0401
- Company Name
- OSARTIS GmbH
- Labeler DUNS
- 344261631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 1
- Public Version Date
- 2022-12-09
- Public Version Status
- New
- Public Device Record Key
- 7cee52b2-60e0-4526-9e8d-6059c61945e9
Device Description
The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JDY | Evacuator, Vapor, Cement Monomer | Orthopedic | 888.4220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60520 | Orthopaedic material preparation vacuum pump | A pneumatically-powered device intended to create negative pressure (vacuum) during orthopaedic cement/filler mixing to help improve the quality of the resulting cement/filler (e.g., reduced porosity and fatigue). It is typically a portable unit containing a pump with a pressure dial/display and control(s), and is usually used in conjunction with an orthopaedic cement-mixing container and fume evacuation/filtering devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260056881633 | GS1 |