Duns Number:002348191
Device Description: HELIUM: HZL 105 LITER 22 16 PS
Catalog Number
IAH-09048
Brand Name
ARROW
Version/Model Number
IPN000266
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
-
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
K060309,K060309
Product Code
DSP
Product Code Name
System, balloon, intra-aortic and control
Public Device Record Key
8d45f60e-e676-4f02-97ef-832849285241
Public Version Date
August 31, 2022
Public Version Number
9
DI Record Publish Date
October 16, 2015
Package DI Number
30801902086762
Quantity per Package
1
Contains DI Package
00801902086761
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 |