FDA UDI
In Commercial Distribution
🇺🇸 United States
UREA NITROGEN (BERTHELOT)
DI: 00852223007119
·
Model: 2290-L
·
STERLING DIAGNOSTICS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UREA NITROGEN (BERTHELOT)
- Primary DI
- 00852223007119
- Version / Model
- 2290-L
- Catalog Number
- 2290-L
- Company Name
- STERLING DIAGNOSTICS INC
- Labeler DUNS
- 155284151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2018-04-17
- Public Version Status
- Update
- Public Device Record Key
- f5ee06d6-03e1-4825-9b85-a4be733a8e18
Device Description
UREA NITROGEN/COLOR (BERTHELOT)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53590 | Urea 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 urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852223007119 | GS1 |