FDA UDI
In Commercial Distribution
🇺🇸 United States
COULTER Retic-X
DI: 15099590233785
·
Model: 628028
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COULTER Retic-X
- Primary DI
- 15099590233785
- Version / Model
- 628028
- Catalog Number
- 628028
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- 73e70ca2-64ca-4576-ab66-2e1cecacfd22
Device Description
COULTER Retic-X Cell Control
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30537 | Reticulocyte count IVD, control | A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590233785 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius