Duns Number:926911454
Device Description: HemaPrompt FG Fecal and Gastric Test Kit
Catalog Number
-
Brand Name
HemaPrompt FG
Version/Model Number
HPFG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K972763,K972763
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
3ee0047f-f755-4c89-8735-eb6e5aa346b0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-