FDA UDI
In Commercial Distribution
🇺🇸 United States
CareSens S
DI: 10385540109749
·
Model: 8000-10974
·
AgaMatrix, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
8
Pkg Device Count
50
Basic Information
- Brand Name
- CareSens S
- Primary DI
- 10385540109749
- Version / Model
- 8000-10974
- Company Name
- AgaMatrix, Inc.
- Labeler DUNS
- 156756129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-08-04
- Public Version
- 3
- Public Version Date
- 2025-11-13
- Public Version Status
- Update
- Public Device Record Key
- 4070304d-d53e-4e2b-8b03-4fb2bb9f3e2d
Device Description
CareSens S Test Strip 50ct Vial
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
- 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 |
|---|---|---|---|---|
| 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 | 00385540109742 | GS1 | Retail Carton | 1 | In Commercial Distribution | |
| Primary | 10385540109749 | GS1 | ||||
| Package | 20385540109746 | GS1 | Shipper | 24 | In Commercial Distribution | |
| Package | 30385540109743 | GS1 | Outer Shipper | 20 | In Commercial Distribution | |
| Package | 00385540109766 | GS1 | Retail Carton | 2 | In Commercial Distribution | |
| Package | 20385540109760 | GS1 | Shipper | 12 | In Commercial Distribution | |
| Package | 30385540109767 | GS1 | Outer Shipper | 8 | In Commercial Distribution | |
| Unit of Use | 08038554010970 | GS1 |
Customer Contacts
- Phone
- 1-800-880-3034
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180866 | 000 |