Duns Number:106793995
Device Description: SYSMEX: Sample Cup, 2mL, for use with Sysmex CA Series analyzers
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
5531
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
704411c8-1db1-410a-82da-1c929999d846
Public Version Date
January 22, 2021
Public Version Number
2
DI Record Publish Date
November 26, 2019
Package DI Number
00840095607797
Quantity per Package
12
Contains DI Package
00840095607780
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |