FDA UDI
In Commercial Distribution
🇺🇸 United States
StatStrip
DI: 00385480636858
·
Model: 63685
·
NOVA BIOMEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StatStrip
- Primary DI
- 00385480636858
- Version / Model
- 63685
- Catalog Number
- 63685
- Company Name
- NOVA BIOMEDICAL CORPORATION
- Labeler DUNS
- 070617139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-28
- Public Version
- 1
- Public Version Date
- 2024-04-05
- Public Version Status
- New
- Public Device Record Key
- 2a2c34df-2b1c-4418-b695-42085c133ef7
Device Description
StatStrip Glucose Hospital Meter System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZI | Prescription use blood glucose meter for near-patient testing | 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 |
|---|---|---|---|---|---|---|
| Primary | 00385480636858 | GS1 |
Customer Contacts
- Phone
- +18005456682
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232075 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Relative Humidity: Up to 90% (noncondensing)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Altitude: Up to 15,000 feet