Duns Number:120664557
Device Description: H2H Rinse Line and packaging information
Catalog Number
-
Brand Name
H2H Rinse Line
Version/Model Number
70-5827
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112314,K112314
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
aaf06adc-752e-4590-bfd9-0cbd3b1d229a
Public Version Date
September 17, 2021
Public Version Number
5
DI Record Publish Date
December 21, 2017
Package DI Number
10896241002364
Quantity per Package
80
Contains DI Package
00896241002367
Package Discontinue Date
September 16, 2021
Package Status
Not in Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |