Duns Number:514832786
Device Description: The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to coll The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.
Catalog Number
-
Brand Name
IDKIT: HP ONE
Version/Model Number
AC00051
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173772,K173772,K173772,K173772
Product Code
-
Product Code Name
-
Public Device Record Key
43e5b6ba-8db6-4313-8b56-2725e5c2b75a
Public Version Date
December 23, 2021
Public Version Number
1
DI Record Publish Date
December 15, 2021
Package DI Number
70350402100136
Quantity per Package
4
Contains DI Package
00350402100137
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 | 3 |