Duns Number:118380146
Device Description: 131" (333 cm) Single Lead Transfer Set w/Clamp, Luer Lock
Catalog Number
PA01
Brand Name
ICU Medical
Version/Model Number
PA01
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
K913804,K913804
Product Code
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
8f8e1bc7-bc9f-433e-86a8-4faa016e43f9
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 29, 2021
Package DI Number
10887709079752
Quantity per Package
30
Contains DI Package
00887709079755
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 |