FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD BBL Crystal™ MIND Software
DI: 00382904410100
·
Model: 441010
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BBL Crystal™ MIND Software
- Primary DI
- 00382904410100
- Version / Model
- 441010
- Catalog Number
- 441010
- 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
- 2018-05-25
- Public Version
- 5
- Public Version Date
- 2023-10-11
- Public Version Status
- Update
- Public Device Record Key
- 3873a581-1dba-4f95-bfbe-f3384c596185
- Distribution End Date
- 2022-09-15
Device Description
Software Crystal Mind
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| LRH | INSTRUMENT FOR AUTO READER OF OVERNIGHT MICROORGANISM IDENTIFICATION SYSTEM | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61487 | Human infectome analysis interpretive software IVD | An in vitro diagnostic interpretive software program intended to be used to aid the identification of infectious microbial species [bacterial, fungal, viral] in a clinical specimen using images from microbial cultures and laboratory biochemical tests (e.g., digital profiles), or by genetic profiling via nucleic acid analysis. Results from in vitro diagnostic tests are input and the presumptive name(s), probability of possible microbial species, and/or information on genetic variants (e.g., subtype, genotype, strain) are returned. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904410100 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature