Duns Number:087248183
Device Description: R&D Glu/Hgb: 6 x 1.5mL High Pack
Catalog Number
GH00H
Brand Name
Research and Diagnostic Systems
Version/Model Number
GH00H
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
-
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
K993321,K993321
Product Code
GGM
Product Code Name
Control, Hemoglobin
Public Device Record Key
70764094-7e62-4b30-b9a3-649eca69f54a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 135 |