FDA UDI
In Commercial Distribution
🇺🇸 United States
AS-500 Anaerobic Chamber
DI: 00810048901456
·
Model: AS-500
·
ANAEROBE SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AS-500 Anaerobic Chamber
- Primary DI
- 00810048901456
- Version / Model
- AS-500
- Catalog Number
- AS-500
- Company Name
- ANAEROBE SYSTEMS
- Labeler DUNS
- 021192653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-01
- Public Version
- 1
- Public Version Date
- 2020-05-11
- Public Version Status
- New
- Public Device Record Key
- 81a57439-4c23-48e3-915b-db40571a3662
Device Description
AS-500 Anaerobic Chamber is a gloveless anaerobic workstation with a 480 plate capacity in the enclosed incubator. 44" x 28" interior work area.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JTM | Anaerobic Box Glove | Microbiology | 866.2120 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16335 | Anaerobic chamber | An airtight chamber filled with a mixture of oxygen-free gases designed to allow laboratory personnel to culture specimens, observe growth, perform subsequent testing, and incubate cultures under anaerobic conditions. It is typically in the form of a framework covered with a thick, transparent, flexible polyvinyl chloride (PVC) with glove boxes (i.e., sleeve-like ports placed in the sides of the chamber that terminate in thick gloves) which allow the operators to operate and manipulate the object placed in the chamber without compromising it atmosphere. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810048901456 | GS1 |
Customer Contacts
- Phone
- 1-800-443-3108
- [email protected]