Duns Number:002348191
Device Description: MAC(TM) Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve for use with 7 MAC(TM) Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve for use with 7 - 7.5 Fr. Catheters
Catalog Number
AK-11142-SPCS
Brand Name
ARROW
Version/Model Number
IPN033903
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K002507,K002507
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
2e4a2846-2764-4eb8-af5e-80a1f9e94df7
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
30801902078248
Quantity per Package
5
Contains DI Package
00801902078247
Package Discontinue Date
August 28, 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 |