Duns Number:830767898
Device Description: SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previously Hosp SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previously Hospira product)
Catalog Number
1640002
Brand Name
Sapphire
Version/Model Number
1640002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K171346,K171346
Product Code
MRZ
Product Code Name
ACCESSORIES, PUMP, INFUSION
Public Device Record Key
06b4cb36-f573-4d7b-abf5-22aa55c83f23
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 31, 2018
Package DI Number
20887787007538
Quantity per Package
48
Contains DI Package
10887787007531
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |