Duns Number:025460908
Device Description: RADIAL PACK
Catalog Number
DYNDA1453A
Brand Name
MEDLINE
Version/Model Number
DYNDA1453A
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
-
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
27a801e5-def3-46c8-9420-a66696ad7728
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
April 20, 2020
Package DI Number
20193489191469
Quantity per Package
5
Contains DI Package
10193489191462
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 |