Duns Number:002348191
Device Description: ISO GARD HEPA LIGHT
Catalog Number
28022
Brand Name
GIBECK
Version/Model Number
IPN044093
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
K954828,K954828,K954828
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
402d5e11-12b0-4980-9dd8-9993abff5ac2
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
24026704348095
Quantity per Package
20
Contains DI Package
04026704348091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |