FDA UDI
In Commercial Distribution
🇺🇸 United States
Recovery Boot 2-115 NRC-LEG
DI: 07290105875372
·
Model: RP 2-115
·
MEGO afek Agricultural Cooperative Society Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Recovery Boot 2-115 NRC-LEG
- Primary DI
- 07290105875372
- Version / Model
- RP 2-115
- Catalog Number
- L41R22B5H
- Company Name
- MEGO afek Agricultural Cooperative Society Ltd
- Labeler DUNS
- 514658082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-24
- Public Version
- 1
- Public Version Date
- 2020-01-01
- Public Version Status
- New
- Public Device Record Key
- 63380688-462b-4595-836a-d62ac7e9341f
Device Description
The Recovery Boot 2-115 NRC-LEG inflatable garment fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
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
- 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 |
|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44768 | Multi-chamber venous compression system garment, reusable | An inflatable device in the form of a stocking, sleeve, or suit that is 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 sequential inflation of several chambers. 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290105875372 | GS1 |
Customer Contacts
- Phone
- 8557327867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060220 | 000 |