Duns Number:002348191
Device Description: HUMID-VENT HEPA, TETHERED CAP
Catalog Number
29002T
Brand Name
GIBECK
Version/Model Number
IPN044135
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
K112958,K112958,K112958
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
68563faf-0b6b-45a6-b0dd-a09ca7a16160
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
24026704400816
Quantity per Package
20
Contains DI Package
04026704400812
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 |