FDA UDI
In Commercial Distribution
🇺🇸 United States
CareSens II
DI: 00885325001266
·
Model: 164221
·
i-SENS, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CareSens II
- Primary DI
- 00885325001266
- Version / Model
- 164221
- Company Name
- i-SENS, Inc.
- Labeler DUNS
- 688840958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-11
- Public Version
- 1
- Public Version Date
- 2020-11-19
- Public Version Status
- New
- Public Device Record Key
- 29324cd6-b88e-42d7-8138-80a918fc9a76
Device Description
CareSens II Blood Glucose Monitoring System (Basic meter set)
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
- 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 |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. 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 |
|---|---|---|---|---|---|---|
| Package | 10885325001263 | GS1 | Master Case Carton | 70 | In Commercial Distribution | |
| Primary | 00885325001266 | GS1 |
Customer Contacts
- Phone
- 1-800-429-5001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080923 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 122 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity