FDA UDI
In Commercial Distribution
🇺🇸 United States
AnaeroGRO
DI: 00819398026338
·
Model: AG25H
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- AnaeroGRO
- Primary DI
- 00819398026338
- Version / Model
- AG25H
- Catalog Number
- AG25H
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-05-13
- Public Version
- 1
- Public Version Date
- 2020-05-21
- Public Version Status
- New
- Public Device Record Key
- 853043d4-d633-4911-b584-b9f512064f51
Device Description
Anaerobic Transport Medium, 15x103mm Tube with Hungate Septum Cap and No Swabs, 7ml. Hardy Diagnostics AnaeroGRO™ Anaerobic Transport Medium is recommended for use in maintaining the viability of obligate anaerobic microorganisms, as well as aerobic and facultatively anaerobic bacteria, during transport. Starswab™ Anaerobic Transport Systems are enclosed, self-contained, ready-to-use, sterile surgery packs, available with or without swabs, for maintaining anaerobic transport of clinical specimens.
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 |
|---|---|---|---|---|
| JSL | Culture Media, Anaerobic Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33355 | Anaerobic transport medium IVD | A vessel containing transport medium intended to be used for the preservation and transport of anaerobic microorganisms from a clinical specimen. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398026321 | GS1 | ||||
| Primary | 00819398026338 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944847 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius