Duns Number:080935429
Device Description: 5-in-1 Bubble Connector,Polyethylene
Catalog Number
8888270603
Brand Name
Argyle
Version/Model Number
8888270603
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCD
Product Code Name
CONNECTOR, CATHETER
Public Device Record Key
fdf3bf36-726a-4dd8-8b95-6465afd25cfd
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 27, 2018
Package DI Number
20884527019363
Quantity per Package
100
Contains DI Package
10884527019366
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |