Duns Number:354765570
Device Description: PF 105-3 Double-Sided Tape Strip (100 pcs)
Catalog Number
-
Brand Name
PF 105-3 Double-Sided Tape Strip
Version/Model Number
PF 105-3
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"
-
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
K974285,K974285
Product Code
DPW
Product Code Name
Flowmeter, Blood, Cardiovascular
Public Device Record Key
7b6e6267-516c-4c1c-be56-a8c6cae72887
Public Version Date
May 25, 2021
Public Version Number
4
DI Record Publish Date
September 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |