FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDI
DI: 00636257002162
·
Model: CSWL085S28
·
MEDI MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDI
- Primary DI
- 00636257002162
- Version / Model
- CSWL085S28
- Company Name
- MEDI MANUFACTURING, INC.
- Labeler DUNS
- 960754430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-23
- Public Version
- 1
- Public Version Date
- 2019-09-02
- Public Version Status
- New
- Public Device Record Key
- 311d6d25-14c5-47d9-8660-d3cf49b6179b
Device Description
MEDI PCS 8 CH WHOLE LEG BLK SM 28
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 44769 | Single-chamber venous compression system garment, single-use | An 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 intermittent inflation of a single-chamber. 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00636257002162 | GS1 |
Customer Contacts
- Phone
- +1(800)633-6334
- [email protected]