Duns Number:967174850
Device Description: InspiraChamber Anti-Static Valved Holding Chamber (Teleflex medical) 1001-50
Catalog Number
-
Brand Name
InspiraChamber Valved Holding Chamber
Version/Model Number
1001-50
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
K130598,K130598
Product Code
NVP
Product Code Name
Holding Chambers, Direct Patient Interface
Public Device Record Key
385f82ba-6c25-4576-aefb-bba479ba88d2
Public Version Date
July 24, 2019
Public Version Number
1
DI Record Publish Date
July 16, 2019
Package DI Number
10852367007065
Quantity per Package
50
Contains DI Package
00852367007068
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |