FDA UDI
In Commercial Distribution
🇺🇸 United States
STATSTRIP
DI: 00385480474887
·
Model: 1.0
·
NOVA BIOMEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STATSTRIP
- Primary DI
- 00385480474887
- Version / Model
- 1.0
- Catalog Number
- 47488
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 602289d4-6294-4d9b-8e9c-cb3ec47beba9
Device Description
StatStrip LAC 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
- No
- 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 |
|---|---|---|---|---|
| KHP | ACID, LACTIC, ENZYMATIC METHOD | Clinical Chemistry | 862.1450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56668 | Metabolic profile clinical chemistry analyser IVD, portable, semi-automated | A portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10385480474884 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00385480474887 | GS1 |
Customer Contacts
- Phone
- +1(800)545-6682
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112955 | 000 |
Storage Conditions
- 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
- Special Storage Condition, Specify
- Special Conditions
- Without Condensation
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity