FDA UDI
In Commercial Distribution
🇺🇸 United States
KETOCOACH 50 BLOOD KETONE TEST STRIPS
DI: 00860060002327
·
Model: S5640791
·
AMVENTUREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KETOCOACH 50 BLOOD KETONE TEST STRIPS
- Primary DI
- 00860060002327
- Version / Model
- S5640791
- Company Name
- AMVENTUREX, INC.
- Labeler DUNS
- 117225590
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-30
- Public Version
- 1
- Public Version Date
- 2020-01-07
- Public Version Status
- New
- Public Device Record Key
- 5fd3d4b7-3c10-4ed2-afe5-43c5b63d41f4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00860060002327 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182593 | 000 |