Duns Number:025460908
Device Description: ARTERIAL LINE START KIT W/O CATH
Catalog Number
P42453
Brand Name
OTHER
Version/Model Number
P42453
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
-
Product Code
CBT
Product Code Name
Arterial blood sampling kit
Public Device Record Key
c7c894da-d607-4238-8333-17f25f346b4f
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 13, 2021
Package DI Number
00653160323795
Quantity per Package
15
Contains DI Package
10653160323792
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |