FDA UDI
In Commercial Distribution
🇺🇸 United States
DOCTOR'S KIT DKS RhD-25
DI: 05713494000351
·
Model: 669-00v07
·
Eldon Biologicals A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
75
Basic Information
- Brand Name
- DOCTOR'S KIT DKS RhD-25
- Primary DI
- 05713494000351
- Version / Model
- 669-00v07
- Catalog Number
- 669-00
- Company Name
- Eldon Biologicals A/S
- Labeler DUNS
- 307910120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2016-12-13
- Public Version
- 5
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 62a6323b-d9c0-4dc4-8585-baee4dae103d
Device Description
For 75 RhD blood group determinations. Not for use for screening purposes prior to transfusion. Dry format cards for RhD determination for the grouping of stabilized venous blood, capillary blood or washed red cells.
Device Characteristics
- Single Use
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52647 | Anti-Rh(D) red blood cell grouping IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Rh(D) [RH001] red blood cell antigens from the rhesus system, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713494000351 | GS1 | ||||
| Unit of Use | 05713494000320 | GS1 |
Customer Contacts
- Phone
- +4545931111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K790282 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 37 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 37 Degrees Celsius