Duns Number:785952607
Device Description: CIRRUS2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOLITE MASK KIT WITH TUBE 2.1M, SINGLE PATIE CIRRUS2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOLITE MASK KIT WITH TUBE 2.1M, SINGLE PATIENT USE
Catalog Number
-
Brand Name
CIRRUS2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOLITE MASK KIT WITH TUBE 2.1M
Version/Model Number
1454013
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K911422,K911422
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
3f12967f-7100-4b1f-9d01-6e5611ebf904
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 2022
Package DI Number
05030267122554
Quantity per Package
36
Contains DI Package
05030267122547
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |