FDA UDI
In Commercial Distribution
🇺🇸 United States
Starrsed Control
DI: 08719189137125
·
Model: QRR049002
·
RR Mechatronics Manufacturing B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Starrsed Control
- Primary DI
- 08719189137125
- Version / Model
- QRR049002
- Company Name
- RR Mechatronics Manufacturing B.V.
- Labeler DUNS
- 491828953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- d5bba400-a534-4878-9fd0-1ea4edf70a25
Device Description
Control blood for Starrsed Instruments and procedures
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKB | DEVICE, AUTOMATED SEDIMENTATION RATE | Hematology | 864.5800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55972 | Erythrocyte sedimentation rate (ESR) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08719189137170 | GS1 | Blister Pack | 6 | In Commercial Distribution | |
| Primary | 08719189137125 | GS1 |
Customer Contacts
- Phone
- +1 401 431-6101
- [email protected]