Duns Number:627879687
Device Description: Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introducer, 16 Fr CryoDecompression Tube (CDT), Dual Lumen, Connector, Suction Tubing and is used with the truFreeze Spray Cryotherapy System.
Catalog Number
2000516
Brand Name
truFreeze
Version/Model Number
2000516
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
K113021,K133258,K143625,K150920,K152668,K160273,K161557,K162695,K163244,K171522,K171626,K172041,K222272,K113021,K133258,K143625,K150920,K152668,K160273,K161557,K162695,K163244,K171522,K171626,K172041,K222272,K113021,K133258,K143625,K150920,K152668,K160273,K161557,K162695,K163244,K171522,K171626,K172041,K222272
Product Code
GEH
Product Code Name
UNIT, CRYOSURGICAL, ACCESSORIES
Public Device Record Key
1fa359e3-3918-465e-b579-176f2cec5a90
Public Version Date
October 04, 2022
Public Version Number
2
DI Record Publish Date
May 04, 2022
Package DI Number
10724995199323
Quantity per Package
5
Contains DI Package
00724995199326
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |