FDA UDI
In Commercial Distribution
🇺🇸 United States
PREVI™ Isola Applicator Cartrige
DI: 03573026613112
·
Model: PREVI™ Isola Applicator Cartrige
·
BIOMERIEUX , INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
120
Basic Information
- Brand Name
- PREVI™ Isola Applicator Cartrige
- Primary DI
- 03573026613112
- Version / Model
- PREVI™ Isola Applicator Cartrige
- Company Name
- BIOMERIEUX , INC.
- Labeler DUNS
- 086785110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 120
- Record Status
- Published
- Publish Date
- 2020-06-26
- Public Version
- 2
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- 6ddf5fb8-c9db-4b1d-9311-6d714862e8b9
Device Description
PREVI ISOLA APPLICATORS CARTRIDGE
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63707 | Inoculating tool IVD, analyser/instrument | A component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026219680 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 03573026613112 | GS1 | ||||
| Unit of Use | 03573026612863 | GS1 |