Duns Number:118380146
Device Description: 105" (267 cm) Y-Type 10 Drop Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Micr 105" (267 cm) Y-Type 10 Drop Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave™ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 62.5 mL
Catalog Number
MRSB-105
Brand Name
ICU Medical
Version/Model Number
MRSB-105
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
K964435,K964435
Product Code
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
4282c16d-53d2-467e-94d7-cfca746d9927
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 2021
Package DI Number
10840619090804
Quantity per Package
25
Contains DI Package
00840619090807
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |