Duns Number:125006353
Device Description: Anoxomat standard jars are available in a variety of sizes. The system capacity can be upd Anoxomat standard jars are available in a variety of sizes. The system capacity can be updated and expanded at any time according to your laboratory's needs.
Catalog Number
AJ9025
Brand Name
Advanced Instruments Standard Anoxomat Jar, Medium
Version/Model Number
AJ9025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZJ
Product Code Name
Device, Gas Generating
Public Device Record Key
d7d1f48c-3ec3-4a8d-8b90-d74d62e26dfe
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 50 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |