Duns Number:084527241
Device Description: 6982PV-1 -- 00842430114960 PKIT, AXIS, LPV, SG, W/TUBING 6982PV -- 10842430114967 PKIT, AX 6982PV-1 -- 00842430114960 PKIT, AXIS, LPV, SG, W/TUBING 6982PV -- 10842430114967 PKIT, AXIS, LPV, SG, W/TUBING, 6/CS 6982PV-2 -- 20842430114964 PKIT, AXIS, LPV, SG, W/TUBING (3/CS)
Catalog Number
6982PV
Brand Name
PKIT, AXIS, LPV, SG, W/TUBING
Version/Model Number
6982PV-1
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
780044ae-5180-4a08-9373-08ab85a9138e
Public Version Date
July 15, 2021
Public Version Number
3
DI Record Publish Date
September 09, 2020
Package DI Number
10842430114967
Quantity per Package
6
Contains DI Package
00842430114960
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1076 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |