FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE INDUSTRIES, INC.
DI: 10888277365940
·
Model: MPH3550FL
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE INDUSTRIES, INC.
- Primary DI
- 10888277365940
- Version / Model
- MPH3550FL
- Catalog Number
- MPH3550FL
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-01
- Public Version
- 1
- Public Version Date
- 2021-10-11
- Public Version Status
- New
- Public Device Record Key
- 2d489694-e7f4-4b07-be28-506307a6a487
Device Description
STRIP, GLUCOSE, FOIL, G3, PROF.USE ONLY
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
- Yes
- 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 |
|---|---|---|---|---|
| NBW | System, test, blood glucose, over the counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42391 | Capillary thermometer cover | A device intended to be used as a physical barrier for an alcohol or mercury capillary thermometer to prevent cross-contamination between patients and/or environmental exposure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30888277365944 | GS1 | BOX | 50 | In Commercial Distribution | |
| Primary | 10888277365940 | GS1 | ||||
| Package | 40888277365941 | GS1 | CASE | 600 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120448 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Protect from freezing, avoid excessive heat.