Duns Number:831704841
Device Description: ambIT Kit with Spike Filter Cassette
Catalog Number
220561
Brand Name
ambIT
Version/Model Number
220561
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OFQ
Product Code Name
Anesthesia Kit
Public Device Record Key
2db793e2-378e-4a47-b35d-e614ce8db8b2
Public Version Date
January 27, 2020
Public Version Number
1
DI Record Publish Date
January 17, 2020
Package DI Number
20857595005972
Quantity per Package
5
Contains DI Package
00857595005978
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 70 |