Duns Number:009299017
Device Description: PEDIATRIC ULTRAFLEX CIRCUIT
Catalog Number
21816P-13621
Brand Name
PEDIATRIC ULTRA FLEX®
Version/Model Number
21816P-13621
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"
Yes
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
CAI
Product Code Name
Circuit, breathing (w connector, adaptor, y piece)
Public Device Record Key
c7131b69-ec6a-4690-818b-71d6047eb9ed
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 28, 2019
Package DI Number
00612649213897
Quantity per Package
20
Contains DI Package
00612649213903
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 | 717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |