Duns Number:112569116
Device Description: PS3400 SERIES,VAC REG,INTERMITTENT,150MMHG,DIGITAL,PRE-SET
Catalog Number
-
Brand Name
Precision Medical Inc.
Version/Model Number
PS3400D
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
-
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
K944479
Product Code
KDP
Product Code Name
Regulator, Vacuum
Public Device Record Key
e8d7b9f7-634d-42cc-ab73-d4b131cb5865
Public Version Date
April 28, 2021
Public Version Number
6
DI Record Publish Date
February 18, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 106 |