FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398020718
·
Model: K112
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398020718
- Version / Model
- K112
- Catalog Number
- K112
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-05-24
- Public Version
- 1
- Public Version Date
- 2020-06-01
- Public Version Status
- New
- Public Device Record Key
- 7adef76b-7ca9-4488-acee-9672c8509949
Device Description
Todd Hewitt Broth, 15x103mm Tube, 1ml. Hardy Diagnostics Todd Hewitt Broth is recommended for the production of antigenic streptococcal hemolysin and the cultivation of streptococci prior to serological grouping. It is also recommended for the cultivation of beta-hemolytic streptococci, pneumococci, and other fastidious organisms.
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
- 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 |
|---|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | Microbiology | 866.2350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58586 | Basic/simple nutrient broth culture medium IVD | A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious 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 | 00819398020701 | GS1 | ||||
| Primary | 00819398020718 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius