FDA UDI
In Commercial Distribution
🇺🇸 United States
PRECICHEK AutoCode AC300
DI: 04260236850985
·
Model: 3K-01-16003F
·
HMD BIOMEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PRECICHEK AutoCode AC300
- Primary DI
- 04260236850985
- Version / Model
- 3K-01-16003F
- Catalog Number
- 3K-01-16003F
- Company Name
- HMD BIOMEDICAL INC.
- Labeler DUNS
- 658644174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-12
- Public Version
- 1
- Public Version Date
- 2020-05-20
- Public Version Status
- New
- Public Device Record Key
- fba8769c-3166-4110-9aee-df2c4a487db4
Device Description
PRECICHEK AutoCode AC300 Blood Glucose Mete
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
- No
- 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 |
|---|---|---|---|---|
| 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 | 04260236850985 | GS1 | ||||
| Package | 00389154000846 | GS1 | KIT | 60 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120064 | 000 |