FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BREEZE® 2
DI: 10301931490012
·
Model: 1490A
·
ASCENSIA DIABETES CARE US INC.
Product Codes
2
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- BREEZE® 2
- Primary DI
- 10301931490012
- Version / Model
- 1490A
- Catalog Number
- 1490A
- Company Name
- ASCENSIA DIABETES CARE US INC.
- Labeler DUNS
- 080028910
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- 56ab0df8-e356-4fc1-b5e9-2644d3717087
- Distribution End Date
- 2018-01-25
Device Description
Control Solution - Low, 1 x 2.5 mL
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50301931490010 | GS1 | out.shipper/lg.case | 32 | Not in Commercial Distribution | 2018-01-25 |
| Package | 40301931490013 | GS1 | in.shipper/sm.case | 12 | Not in Commercial Distribution | 2018-01-25 |
| Package | 00301931490015 | GS1 | carton | 1 | Not in Commercial Distribution | 2018-01-25 |
| Primary | 10301931490012 | GS1 | ||||
| Secondary | 0193-1490-01 | NDC/NHRIC |
Customer Contacts
- Phone
- 18003488100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062347 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight. Do not use after expiration date.
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit