FDA UDI
In Commercial Distribution
🇺🇸 United States
Antiplatelet Reagent
DI: 20812747018590
·
Model: 07-670-US
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
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Basic Information
- Brand Name
- Antiplatelet Reagent
- Primary DI
- 20812747018590
- Version / Model
- 07-670-US
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2025-05-20
- Public Version
- 1
- Public Version Date
- 2025-05-28
- Public Version Status
- New
- Public Device Record Key
- 093ce9f7-7421-424d-85d5-3cf343d23dac
Device Description
ANTIPLATELET REAGENT, US
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
- 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 |
|---|---|---|---|---|
| PPM | General purpose reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67526 | Antiplatelet reagent IVD | A substance intended to be used to decrease platelet function in a whole blood specimen by inhibiting platelet activation and/or aggregation in preparation for subsequent analysis. It typically contains a platelet activation and/or aggregation inhibitor (e.g., abciximab), buffers and stabilizers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00812747018596 | GS1 | ||||
| Primary | 20812747018590 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius