Duns Number:094651270
Device Description: UNIVERSAL CAPS, MALE / FEMALE. NON-VENTED, 2-PACK
Catalog Number
600-400
Brand Name
N/A
Version/Model Number
Caps
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
2a499ec0-4a21-47fb-b022-669ee9cff717
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H6716004001
Quantity per Package
50
Contains DI Package
H6716004000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 35 |
2 | A medical device with a moderate to high risk that requires special controls. | 274 |