Duns Number:118380146
Device Description: 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave®, Remv 2 Gang 4-Way 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave®, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext
Catalog Number
-
Brand Name
ICU Medical
Version/Model Number
Z3550
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983559,K983559
Product Code
FJK
Product Code Name
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Public Device Record Key
2f92a850-9298-4de7-ad4b-0968e67b077f
Public Version Date
November 19, 2020
Public Version Number
6
DI Record Publish Date
October 31, 2017
Package DI Number
10887709033341
Quantity per Package
25
Contains DI Package
00887709033344
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4887 |