Duns Number:176458115
Device Description: For the quantitative determination of hemoglobin in non-anticoagulated capillary whole blo For the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA or sodium heparin. The testing system is designed for point-of-care use in primary care settings.
Catalog Number
-
Brand Name
AIMSTRIP HEMOGLOBIN METER
Version/Model Number
78101
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GKR
Product Code Name
System, Hemoglobin, Automated
Public Device Record Key
88825c63-f0f2-4cd7-9aa9-cd1f7311c4e8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 11, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |