Duns Number:002348191
Device Description: Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis
Catalog Number
AK-01000-T
Brand Name
ARROW
Version/Model Number
IPN039282
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
c8765ecc-6578-49d5-a4cc-99f13de07a81
Public Version Date
March 25, 2022
Public Version Number
4
DI Record Publish Date
March 07, 2019
Package DI Number
20801902145127
Quantity per Package
10
Contains DI Package
10801902145120
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 | 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 |