FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00816576027019
·
Model: J62
·
HARDY DIAGNOSTICS
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- N/A
- Primary DI
- 00816576027019
- Version / Model
- J62
- Catalog Number
- J62
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-06-01
- Public Version
- 1
- Public Version Date
- 2020-06-09
- Public Version Status
- New
- Public Device Record Key
- 25fdc74a-b25c-426a-b889-82bed2215007
Device Description
CNA/MacConkey Biplate, 15x100, biplate, 10/pk (Columbia Agar with 5% Sheep Blood Colistin and Nalidixic Acid/MacConkey Agar) Some ingredients are very light sensitive. Store and incubate media in the dark.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JSI | Culture Media, Selective And Differential | Microbiology | 866.2360 | 1 |
| JSH | Culture Media, Non-Selective And Differential | Microbiology | 866.2320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62106 | Multiple formulation agar culture medium IVD | A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00816576027002 | GS1 | ||||
| Primary | 00816576027019 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store media in the dark