FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica HEMA RET/PLTO
DI: 00630414290010
·
Model: 11374309
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- Atellica HEMA RET/PLTO
- Primary DI
- 00630414290010
- Version / Model
- 11374309
- Catalog Number
- 11374309
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- dd27e505-db15-4b7c-9744-33c69cecd8fa
Device Description
AT HEMA RET PLTO
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LED | STAINS, CHEMICAL SOLUTION | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55854 | Full blood count IVD, kit, cell count | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00630414312484 | GS1 | ||||
| Primary | 00630414290010 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius