FDA UDI
In Commercial Distribution
🇺🇸 United States
IDG/Sanzay
DI: 00850053916069
·
Model: 1
·
IDG/SANZAY Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDG/Sanzay
- Primary DI
- 00850053916069
- Version / Model
- 1
- Catalog Number
- C095
- Company Name
- IDG/SANZAY Corporation
- Labeler DUNS
- 948875013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-09
- Public Version
- 1
- Public Version Date
- 2024-01-17
- Public Version Status
- New
- Public Device Record Key
- 140a4e68-9bb6-488f-a2a2-138e3a814a24
Device Description
Urea nitrogen (BUN) liquid reagent is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in human serum used in routine examination and monitoring of therapy and relapses.
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 |
|---|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | Clinical Chemistry | 862.1770 | 2 |
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 | 00850053916069 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981106 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 100 | Milliliter | |
| Total Volume | 120 | Milliliter | |
| Total Volume | 1 | Liter | |
| Total Volume | 240 | Milliliter | |
| Total Volume | 250 | Milliliter | |
| Total Volume | 500 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius