FDA UDI
In Commercial Distribution
🇺🇸 United States
Dade Hepzyme
DI: 00630414640396
·
Model: 10873841
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Dade Hepzyme
- Primary DI
- 00630414640396
- Version / Model
- 10873841
- Catalog Number
- 10873841
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-03-25
- Public Version
- 1
- Public Version Date
- 2024-04-02
- Public Version Status
- New
- Public Device Record Key
- bf846f26-08bc-4225-83fa-0f570fc04b34
Device Description
Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
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
- 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 |
|---|---|---|---|---|
| JBR | TEST, HEPARIN NEUTRALIZATION | Hematology | 864.7525 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56207 | Coagulation inhibitory substance neutralization IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the neutralization of any coagulation inhibitory substances in a clinical specimen through the addition of phospholipids. This is performed prior to testing using an activated partial thromboplastin time (APTT) test. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00842768019487 | GS1 | ||||
| Primary | 00630414640396 | GS1 |
Customer Contacts
- Phone
- +1(800)242-3233
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925452 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius