FDA UDI
In Commercial Distribution
🇺🇸 United States
KetoSens
DI: 00885325001280
·
Model: 276156
·
i-SENS, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- KetoSens
- Primary DI
- 00885325001280
- Version / Model
- 276156
- Company Name
- i-SENS, Inc.
- Labeler DUNS
- 688840958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-11-10
- Public Version
- 1
- Public Version Date
- 2020-11-18
- Public Version Status
- New
- Public Device Record Key
- 5856a568-f159-42ad-a4e0-e46e702ce719
Device Description
KetoSens B-Ketone 10T Test Strips with 10T lancets
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 |
|---|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | 862.1435 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53341 | Ketone (acetoacetate) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10885325001287 | GS1 | Case Pack,Middle Box | 25 | In Commercial Distribution | |
| Primary | 00885325001280 | GS1 | ||||
| Package | 20885325001284 | GS1 | Master Case Carton | 10 | In Commercial Distribution | |
| Unit of Use | 50885325000875 | GS1 |
Customer Contacts
- Phone
- 1-800-429-5001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170463 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity