FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroScan
DI: 15099590693404
·
Model: B1020-100B
·
Beckman Coulter, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- MicroScan
- Primary DI
- 15099590693404
- Version / Model
- B1020-100B
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2017-08-02
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4cfed81f-80a1-4330-aac6-ac17c2d2d365
Device Description
Detect Neg MIC Panel Type 1
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OTT | Research Use Only/Microbiology | Unknown | N | |
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58605 | General-microorganism antimicrobial susceptibility culture medium IVD | A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590693404 | GS1 | ||||
| Unit of Use | 05099590693407 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius