FDA UDI
In Commercial Distribution
🇺🇸 United States
Movement and Compressions System (MAC)
DI: B547RF14300
·
Model: B
·
Recovery Force Health, LLC
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
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Basic Information
- Brand Name
- Movement and Compressions System (MAC)
- Primary DI
- B547RF14300
- Version / Model
- B
- Catalog Number
- RF1430
- Company Name
- Recovery Force Health, LLC
- Labeler DUNS
- 105958323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-05
- Public Version
- 6
- Public Version Date
- 2025-12-03
- Public Version Status
- Update
- Public Device Record Key
- 18d24d20-dd3f-4fa2-89d9-6d0165886ab0
Device Description
MAC Charger
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10969 | Intermittent venous compression system | A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B547RF14300 | HIBCC | ||||
| Package | B547RF1440237 | HIBCC | Kit | 1 | In Commercial Distribution | |
| Package | B547RF1440207 | HIBCC | Kit | 1 | In Commercial Distribution | |
| Package | B547RF1440217 | HIBCC | Kit | 1 | In Commercial Distribution | |
| Package | B547RF1440227 | HIBCC | Kit | 1 | In Commercial Distribution | |
| Package | B547RF143009 | HIBCC | Box | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 866.604.6458
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203052 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 203 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius