Duns Number:324869601
Device Description: Jackson Rees System I for paediatrics
Catalog Number
-
Brand Name
n.a.
Version/Model Number
67-12-000
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
-
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
1d23c704-c023-4f87-babe-c2a9ab6a607e
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
September 18, 2020
Package DI Number
14250105603863
Quantity per Package
1
Contains DI Package
04250105603866
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 | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |