FDA UDI
In Commercial Distribution
🇺🇸 United States
Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2
DI: 08809040527018
·
Model: AR2-S2-CB1
·
Maxstar Industrial Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2
- Primary DI
- 08809040527018
- Version / Model
- AR2-S2-CB1
- Company Name
- Maxstar Industrial Co.,Ltd.
- Labeler DUNS
- 687844027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-25
- Public Version
- 1
- Public Version Date
- 2022-04-04
- Public Version Status
- New
- Public Device Record Key
- 13547e44-bd59-4dfc-9b92-1f784316be0f
Device Description
Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 (110V US PLUG - With Bag)
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 pump | An electrically-powered device 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 with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. 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 | 08809040527018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191441 | 000 |