Duns Number:065626069
Device Description: Merge Hemo 77-00327-00 Link Assembly
Catalog Number
-
Brand Name
Merge Hemo Link Assembly
Version/Model Number
77-00327-00
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082421
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
cbf03b89-9b14-4564-a16a-4881899bc683
Public Version Date
July 05, 2019
Public Version Number
1
DI Record Publish Date
June 27, 2019
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. | 65 |