FDA UDI
In Commercial Distribution
🇺🇸 United States
PRECICHEK AutoCode foil packed test strip
DI: 04260236851142
·
Model: 3L-10-16003B
·
HMD BIOMEDICAL INC.
Product Codes
3
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PRECICHEK AutoCode foil packed test strip
- Primary DI
- 04260236851142
- Version / Model
- 3L-10-16003B
- Catalog Number
- 3L-10-16003B
- Company Name
- HMD BIOMEDICAL INC.
- Labeler DUNS
- 658644174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-06
- Public Version
- 1
- Public Version Date
- 2020-07-14
- Public Version Status
- New
- Public Device Record Key
- b89eca42-19e8-4008-93ff-086057c0e77c
Device Description
PRECICHEK AutoCode Blood Glucose ACH foil packed test strip
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
- 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
- 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 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53303 | Glucose IVD, kit, electrometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. | No | Active |
| 62766 | Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control | A material which is used to verify the performance of an assay intended to be used to monitor or predict the isocitrate dehydrogenase 2 (IDH2) gene mutation status of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04260236851210 | GS1 | FOIL | 120 | In Commercial Distribution | |
| Primary | 04260236851142 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120064 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity