FDA UDI
In Commercial Distribution
🇺🇸 United States
AN-IDENT DISCSDD6 6X50 DISCS
DI: 05032384007189
·
Model: DD0006A
·
OXOID LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AN-IDENT DISCSDD6 6X50 DISCS
- Primary DI
- 05032384007189
- Version / Model
- DD0006A
- Company Name
- OXOID LIMITED
- Labeler DUNS
- 365355452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-04
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- ffc34725-c930-4094-be8f-399abbdfd440
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45367 | Multiple antimycobacterial susceptibility testing kit IVD | A collection of reagents and other associated materials containing multiple susceptibility testing discs impregnated with a range of antimycobacterial agents (i.e., drugs intended for treatment and/or prevention of a mycobacterial infection) intended to be used to determine the antimicrobial susceptibility profile of a specific Mycobacterium organism, 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 | 05032384007189 | GS1 |