FDA UDI
In Commercial Distribution
🇺🇸 United States
BD CytoRich™ Blue Preservative
DI: 00382904913359
·
Model: 491335
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD CytoRich™ Blue Preservative
- Primary DI
- 00382904913359
- Version / Model
- 491335
- Catalog Number
- 491335
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-27
- Public Version
- 1
- Public Version Date
- 2019-07-05
- Public Version Status
- New
- Public Device Record Key
- 57c50099-fa7d-4369-8720-09ccb3a9f1be
Device Description
BD CytoRich™ Blue 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 |
|---|---|---|---|---|
| LDZ | FIXATIVE, ALCOHOL CONTAINING | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57752 | Saccamanno solution IVD | A solution typically containing 50% ethanol and 2% polyethylene glycol (carbowax) diluted in water, intended to be used as a fixative particularly for liquid cytologic specimens such as sputum, urine, bronchial washings, and pleural and peritoneal fluids. Saccomanno solution causes lysis of red blood cells and renders uncoagulated proteins and mucus soluble for centrifugation and filtration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904913359 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius