Duns Number:005083209
Device Description: Calibration Bag (1000mL)
Catalog Number
H938735
Brand Name
EXACTAMIX
Version/Model Number
H938735
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"
Yes
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
K900585,K900585
Product Code
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
39b47b23-5881-4574-94ff-c30133211c5f
Public Version Date
July 27, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50085412477201
Quantity per Package
50
Contains DI Package
00085412477206
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |