FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Kiestra™ InoqulA+™ TLA
DI: 00382904472139
·
Model: 447213
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Kiestra™ InoqulA+™ TLA
- Primary DI
- 00382904472139
- Version / Model
- 447213
- Catalog Number
- 447213
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 3
- Public Version Date
- 2018-11-08
- Public Version Status
- Update
- Public Device Record Key
- 6d8fedb1-225d-4aa2-88fb-7b7446b01571
Device Description
BD Kiestra™ InoqulA+™ TLA
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
- Yes
- 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 |
|---|---|---|---|---|
| JTC | DEVICE, MICROTITER DILUTING/DISPENSING | Microbiology | 866.2500 | 1 |
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 | 00382904472139 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 27 Degrees Celsius