Duns Number:109903521
Device Description: 3000CC HI-FLOW CANISTERS
Catalog Number
72200024
Brand Name
N/A
Version/Model Number
72200024
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 08, 2017
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
BOTTLE, COLLECTION, VACUUM
Public Device Record Key
ed6cccce-e39c-4bd4-a5e6-38a8585f79d0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 23, 2015
Package DI Number
23596010591504
Quantity per Package
36
Contains DI Package
03596010591500
Package Discontinue Date
August 08, 2017
Package Status
Not in Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |