FDA UDI
In Commercial Distribution
🇺🇸 United States
Hematek® Stain Pak - Wright-Giemsa Stain
DI: 00630414473482
·
Model: 10314755
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hematek® Stain Pak - Wright-Giemsa Stain
- Primary DI
- 00630414473482
- Version / Model
- 10314755
- Catalog Number
- 4405
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 3
- Public Version Date
- 2022-04-29
- Public Version Status
- Update
- Public Device Record Key
- 527d00f8-2f03-4194-b45f-61794f3b8604
Device Description
Hematek® Stain Pak Wright-Giemsa Stain
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 |
|---|---|---|---|---|
| HYF | GIEMSA STAIN | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414473482 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from freezing; Fragile; Protect from light & heat; Flammable
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius