FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Kiestra™ IdentifA
DI: 00382904440633
·
Model: 444063
·
BECTON, DICKINSON AND COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Kiestra™ IdentifA
- Primary DI
- 00382904440633
- Version / Model
- 444063
- Catalog Number
- 444063
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-31
- Public Version
- 2
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- dde81aa3-1b1c-49a9-b026-f6b0694c5fc7
Device Description
BD Kiestra IdentifA
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QBN | Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates | Microbiology | 866.3378 | 2 |
| QQV | Automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry | Microbiology | 866.3378 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61712 | Microbial specimen inoculation/streaking/colony-picking instrument IVD | An electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904440633 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 860 | Millimeter | |
| Width | 1060 | Millimeter | |
| Weight | 550 | Kilogram | |
| Height | 1700 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 27 Degrees Celsius