FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE RENEWAL
DI: 10888277391536
·
Model: 3040R
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- MEDLINE RENEWAL
- Primary DI
- 10888277391536
- Version / Model
- 3040R
- Catalog Number
- 3040R
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- 1344dabf-81b5-4bd5-ab29-d7a1f7787237
Device Description
VENAFLOW ELITE, CALF CUFF, REPROCESSED
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 |
|---|---|---|---|---|
| 61825 | Tourniquet cuff, reprocessed | A band-like device intended to be applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or following serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff may comprise a dual-chamber allowing alternation of the pressure site to avoid tissue damage or necrosis. 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 | 20888277391533 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 10888277391536 | GS1 | ||||
| Unit of Use | 80888277391535 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]