FDA UDI
In Commercial Distribution
🇺🇸 United States
DVT Sleeve
DI: 00816317023140
·
Model: RM-TRP 20
·
RENU MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DVT Sleeve
- Primary DI
- 00816317023140
- Version / Model
- RM-TRP 20
- Company Name
- RENU MEDICAL, INC
- Labeler DUNS
- 100439103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-27
- Public Version
- 5
- Public Version Date
- 2023-09-08
- Public Version Status
- Update
- Public Device Record Key
- ea523530-cf05-4cb7-a21f-ed4b339ed78d
Device Description
Flowtron large sequential calf garment- fits up to 23 in. calf circumference.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 61810 | Multi-chamber venous compression system garment, reprocessed | A non-sterile inflatable device in the form of a stocking, sleeve, or suit intended to be 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 previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816317023147 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 00816317023140 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031559 | 000 |