FDA UDI
In Commercial Distribution
🇺🇸 United States
Dimension Vista® Flex® reagent cartridge THC
DI: 00842768015441
·
Model: 10445116
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Dimension Vista® Flex® reagent cartridge THC
- Primary DI
- 00842768015441
- Version / Model
- 10445116
- Catalog Number
- K5095
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 8526b915-5df0-4c69-9cb1-51c9d7b60b39
Device Description
Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| LDJ | ENZYME IMMUNOASSAY, CANNABINOIDS | Clinical Toxicology | 862.3870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55550 | Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768015441 | GS1 | ||||
| Unit of Use | 00630414004891 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062128 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius