FDA UDI
In Commercial Distribution
🇺🇸 United States
PRAS Chopped Meat Medium w/ Glucose (CMG)
DI: 00810048900671
·
Model: AS-8135
·
ANAEROBE SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRAS Chopped Meat Medium w/ Glucose (CMG)
- Primary DI
- 00810048900671
- Version / Model
- AS-8135
- Catalog Number
- AS-8135
- 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
- 2faff173-accb-4699-bad0-a1585cb6fc39
Device Description
AS-8135 Chopped Meat Medium with Glucose (CMG) will support the growth of most non-sporeforming and sporeforming anaerobes associated with human and animal infections. This media may be used as a maintaining or holding media for stock cultures. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent golden yellow liquid with chopped meat at the bottom. 1 bottle per pack.
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 |
|---|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | Microbiology | 866.2320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58687 | Enriched broth culture medium IVD | A broth culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms, from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow in a general-purpose broth medium. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810048900671 | GS1 |
Customer Contacts
- Phone
- 1-800-443-3108
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius