Duns Number:002348191
Device Description: Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Kit
Catalog Number
ASK-01000-CHP
Brand Name
ARROW
Version/Model Number
IPN039280
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)
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
047748e3-097e-4e28-8866-c4abb7e9aad9
Public Version Date
March 15, 2019
Public Version Number
1
DI Record Publish Date
March 07, 2019
Package DI Number
20801902145103
Quantity per Package
10
Contains DI Package
10801902145106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Peel Pack
| 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 |