FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10888277387232
·
Model: 5921030235R
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10888277387232
- Version / Model
- 5921030235R
- Catalog Number
- 5921030235R
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-09
- Public Version
- 1
- Public Version Date
- 2022-07-18
- Public Version Status
- New
- Public Device Record Key
- 622baeff-16a2-4a31-b5bf-c8107903e9b7
Device Description
5921-030-235 COLOR TRNQT,DPSB,PLC BLUE
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCY | TOURNIQUET, PNEUMATIC | General, Plastic Surgery | 878.5910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61825 | Tourniquet cuff, reprocessed | A sterile, 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 | 40888277387233 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10888277387232 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]