FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD CytoRich™ Clear Preservative
DI: 00382904907198
·
Model: 490719
·
BECTON, DICKINSON AND COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD CytoRich™ Clear Preservative
- Primary DI
- 00382904907198
- Version / Model
- 490719
- Catalog Number
- 490719
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-02
- Public Version
- 2
- Public Version Date
- 2023-12-07
- Public Version Status
- Update
- Public Device Record Key
- 93345eba-cb10-4c3e-a171-0878858397fc
- Distribution End Date
- 2023-10-03
Device Description
Cytorich Clear Preservative
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| LEA | PRESERVATIVE, CYTOLOGICAL | Pathology | 864.4010 | 1 |
| LDZ | FIXATIVE, ALCOHOL CONTAINING | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57743 | Cytology fixative solution IVD | An alcohol-based solution intended to be used as a fixative for a cytology specimen obtained directly from a patient, or processing of a clinical specimen, for subsequent preservation, transportation and/or in vitro diagnostic analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904907198 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius