FDA UDI
In Commercial Distribution
🇺🇸 United States
Air Relax Plus Model AR-3.0 Control Unit Only
DI: 08809040526271
·
Model: AR3
·
Maxstar Industrial Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Air Relax Plus Model AR-3.0 Control Unit Only
- Primary DI
- 08809040526271
- Version / Model
- AR3
- Company Name
- Maxstar Industrial Co.,Ltd.
- Labeler DUNS
- 687844027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-15
- Public Version
- 2
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- f27b47ae-1df4-466c-aa9f-dc8ed0a35d03
Device Description
Air Relax Plus Model AR-3.0 Control Unit Only
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44785 | Sequential venous compression system inflator | An electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809040526271 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211460 | 000 |