FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10080196385409
·
Model: DVT10SR
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10080196385409
- Version / Model
- DVT10SR
- Catalog Number
- DVT10SR
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-01-02
- Public Version
- 1
- Public Version Date
- 2025-01-10
- Public Version Status
- New
- Public Device Record Key
- 5150c3eb-a57a-4c19-84c8-a3c6f31fa6ee
Device Description
DVT10(S) CALF GARMENT, DVT10(S) (1)
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 61809 | Single-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 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 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 | 40080196385400 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 10080196385409 | GS1 | ||||
| Unit of Use | 80080196385408 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]