FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)
DI: 00816068020900
·
Model: Anoxomat III (100V - 120V)
·
ADVANCED INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)
- Primary DI
- 00816068020900
- Version / Model
- Anoxomat III (100V - 120V)
- Catalog Number
- Anoxomat III (100V - 120V)
- Company Name
- ADVANCED INSTRUMENTS, INC.
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- a011469e-6bfa-43d7-8d98-34af422de4bd
Device Description
The Anoxomat system empowers customers to automatically and easily create exact, repeatable atmospheric environments. It is flexible and easy to use, keeping clinical and industrial microbiology labs productive and ready to culture a wide range of microbes.It is flexible and easy to use, keeping clinical and industrial microbiology labs productive and ready to culture a wide range of microbes.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KZJ | Device, Gas Generating | Microbiology | 866.2580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43530 | Anaerobic (AnO2) atmospheric generation IVD | A pouch or unit intended to be used to reduce or deplete atmospheric oxygen (AnO2) to create an anaerobic environment suitable for the cultivation, processing, or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816068020900 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]