FDA UDI
In Commercial Distribution
🇺🇸 United States
STATSTRIP
DI: 00385480467995
·
Model: Ejector
·
NOVA BIOMEDICAL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STATSTRIP
- Primary DI
- 00385480467995
- Version / Model
- Ejector
- Catalog Number
- 46799
- Company Name
- NOVA BIOMEDICAL CORPORATION
- Labeler DUNS
- 070617139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- afd8daa1-cb3c-411e-bd15-1943d2c6787f
Device Description
StatStrip Xpress GLU Meter with Battery and Quick Reference Guide
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62538 | Glucose monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10385480467992 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00385480467995 | GS1 |
Customer Contacts
- Phone
- +1(800)545-6682
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150461 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Without Condensation
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- 0 ft to 15000 ft
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity