FDA UDI
In Commercial Distribution
🇺🇸 United States
Lympholyte-H
DI: 00628451099499
·
Model: CL5026
·
Cedarlane Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Lympholyte-H
- Primary DI
- 00628451099499
- Version / Model
- CL5026
- Catalog Number
- CL5026
- Company Name
- Cedarlane Corporation
- Labeler DUNS
- 243928822
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-10
- Public Version
- 1
- Public Version Date
- 2024-12-18
- Public Version Status
- New
- Public Device Record Key
- 6e032a7d-09b7-444a-8a4d-3f9287b24650
Device Description
Lympholyte-H Cell Separation Media (Isolation of lymphocytes from Human peripheral blood), liquid
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCF | Lymphocyte Separation Medium | Hematology | 864.8500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41427 | Cell centrifugation/density gradient separation reagent IVD | A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628451099499 | GS1 | ||||
| Previous | 06284510990493 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius