Duns Number:173503806
Device Description: Hepa-Care® Ceiling Unit, 220-240 Volt 2 Amp 50 Hz. Motor thermally protected single phase. Hepa-Care® Ceiling Unit, 220-240 Volt 2 Amp 50 Hz. Motor thermally protected single phase. Made in Canada
Catalog Number
-
Brand Name
Hepa-Care®
Version/Model Number
HC800CTF
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K984116
Product Code
FRF
Product Code Name
Cleaner, Air, Medical Recirculating
Public Device Record Key
cc2049cb-dd32-41f2-96b2-77a16414a300
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 11, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |