FDA UDI
In Commercial Distribution
🇺🇸 United States
Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
DI: 03573026606480
·
Model: Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
- Primary DI
- 03573026606480
- Version / Model
- Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-23
- Public Version
- 2
- Public Version Date
- 2022-05-13
- Public Version Status
- Update
- Public Device Record Key
- 36d0246f-2720-45ad-87e0-68b3024aa300
Device Description
BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Pediatric Bottle.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OIB | Blood and urine collection kit (excludes HIV testing) | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58543 | Blood culture broth kit IVD | A collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026601898 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 03573026606480 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius