FDA UDI
In Commercial Distribution
🇺🇸 United States
ComASP
DI: 08058951160436
·
Model: ComASP Cefiderocol 0.008-128
·
LIOFILCHEM SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ComASP
- Primary DI
- 08058951160436
- Version / Model
- ComASP Cefiderocol 0.008-128
- Catalog Number
- 75009U
- Company Name
- LIOFILCHEM SRL
- Labeler DUNS
- 435342134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-31
- Public Version
- 1
- Public Version Date
- 2023-06-08
- Public Version Status
- New
- Public Device Record Key
- 72658733-a2dd-4847-a5ac-19dc4816de2a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42660 | Antibacterial minimum inhibitory concentration (MIC) IVD | A graduated test strip or collection of reagents containing a specified concentration gradient of a specific antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058951160436 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230479 | 000 |