Duns Number:831704841
Device Description: ambIT Kit Basic w Male Luer & Filter Cassette
Catalog Number
220568
Brand Name
ambIT
Version/Model Number
220568
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
e20c7f22-b2e4-4b08-8371-4dc4c8769985
Public Version Date
March 26, 2020
Public Version Number
1
DI Record Publish Date
March 18, 2020
Package DI Number
20850000509003
Quantity per Package
5
Contains DI Package
00850000509009
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 |