Duns Number:830767898
Device Description: Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Lock, 80 Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Lock, 80 Inch (previously Hospira product)
Catalog Number
1273002
Brand Name
Blood Set
Version/Model Number
1273002
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
K143087,K143087
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
1d4505c3-3cf2-4a9f-9ffe-325c939ccdce
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
June 04, 2018
Package DI Number
20887787008832
Quantity per Package
48
Contains DI Package
10887787009146
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |