FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD BBL™ Crystal™ ID Systems Gram-Positive Manual Codebook
DI: 00382902450375
·
Model: 245037
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BBL™ Crystal™ ID Systems Gram-Positive Manual Codebook
- Primary DI
- 00382902450375
- Version / Model
- 245037
- Catalog Number
- 245037
- 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
- 3
- Public Version Date
- 2023-10-20
- Public Version Status
- Update
- Public Device Record Key
- 11440c28-73e6-4754-a392-962493381aa0
- Distribution End Date
- 2022-09-27
Device Description
Codebook Crystal Gram-Positive Manual
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
- No
- 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 |
|---|---|---|---|---|
| LQL | GRAM POSITIVE IDENTIFICATION PANEL | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56742 | Microorganism identification analyser IVD, manual | An electrically-powered manual laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens by characterizing their morphology, substrate utilization and/or biochemical reactivity, using growth detection technology which may include immunoassay, colorimetry, chromatography and/or carbon dioxide (CO2) production. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382902450375 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature