Duns Number:831704841
Device Description: Pain Control System - Basic with Filterless Male Luer Cassette
Catalog Number
220342
Brand Name
ambIT
Version/Model Number
220342
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
b86dcf45-60e9-48a8-9b9e-d7924928f8f3
Public Version Date
December 20, 2019
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
20857595005248
Quantity per Package
5
Contains DI Package
00857595005244
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 |