FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398023818
·
Model: R99
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398023818
- Version / Model
- R99
- Catalog Number
- R99
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-06-05
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- c55f8319-608e-4cb3-b6a9-5b2a325cbff2
Device Description
Viral Transport Medium VTM, 3.1ml fill (swabs sold separately), order by the package of 20 Hardy Diagnostics Viral Transport Medium is recommended for the collection and transport of clinical specimens for the recovery of viral agents including, but not limited to, Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Echovirus, Adenovirus, etc.
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 |
|---|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58697 | Viral transport medium IVD | A vessel containing transport medium intended to be used for the preservation and transport of viral culture isolates from a clinical specimen. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398023801 | GS1 | ||||
| Primary | 00819398023818 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955451 | 000 |