Duns Number:931853006
Device Description: AN1071.16 Humidichip, 16 units
Catalog Number
AN1071.16
Brand Name
AN1071 Humidichip
Version/Model Number
AN1071.16
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150646,K150646
Product Code
FLF
Product Code Name
Sterilizer, Ethylene-Oxide Gas
Public Device Record Key
f95f41e4-3f3a-4f9c-a3be-a58fe7008893
Public Version Date
October 02, 2018
Public Version Number
1
DI Record Publish Date
September 01, 2018
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. | 11 |