Duns Number:002348191
Device Description: Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Kit
Catalog Number
AK-01000-T
Brand Name
ARROW
Version/Model Number
IPN033838
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K870572,K870572
Product Code
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
b8c7c284-1fa1-4bd9-b8cf-993567c21df6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
30801902004797
Quantity per Package
10
Contains DI Package
00801902004796
Package Discontinue Date
June 27, 2017
Package Status
Not 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |