Duns Number:005146311
Device Description: CHEMO-AIDE Dispensing Pin, Reconstitution/Dispensing Device with 0.2 Micron Hydrophobic/Ol CHEMO-AIDE Dispensing Pin, Reconstitution/Dispensing Device with 0.2 Micron Hydrophobic/Oleophobic Air-Venting Filter and Female Luer Adapter
Catalog Number
2N9106
Brand Name
CHEMO-AIDE
Version/Model Number
2N9106
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
K003730,K003730
Product Code
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
e266bc2b-f079-416d-8b45-717a1459ce47
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50085412035135
Quantity per Package
50
Contains DI Package
00085412035130
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |