FDA UDI
In Commercial Distribution
🇺🇸 United States
PRAS Dilution Blanks
DI: 00810048901210
·
Model: AS-918
·
ANAEROBE SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- PRAS Dilution Blanks
- Primary DI
- 00810048901210
- Version / Model
- AS-918
- Catalog Number
- AS-918
- Company Name
- ANAEROBE SYSTEMS
- Labeler DUNS
- 021192653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- 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
- 3b9af2e9-be5a-445e-9852-f4cea5c3bcc9
Device Description
AS-918 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 18 mL fill volume. 20 x 113 mm screw top tube. Transparent colorless liquid. 10 tubes 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 |
|---|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | Microbiology | 866.2350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58208 | Buffered sample diluent IVD, manual | A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810048902439 | GS1 | ||||
| Primary | 00810048901210 | GS1 |
Customer Contacts
- Phone
- 1-800-443-3108
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius