FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10884389181911
·
Model: MPHUA10SG
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Medline
- Primary DI
- 10884389181911
- Version / Model
- MPHUA10SG
- Catalog Number
- MPHUA10SG
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-10
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- c8d7f48b-c1e7-4666-b2ff-a1e50cc37675
Device Description
STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54514 | Multiple urine analyte IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40884389181912 | GS1 | CASE | 24 | In Commercial Distribution | |
| Primary | 10884389181911 | GS1 | ||||
| Unit of Use | 80884389181910 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight.