Duns Number:830767898
Device Description: SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previously Hospira SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previously Hospira product)
Catalog Number
1637201
Brand Name
Sapphire
Version/Model Number
1637201
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
K171346,K171346
Product Code
MRZ
Product Code Name
ACCESSORIES, PUMP, INFUSION
Public Device Record Key
1842e61b-50b5-4781-924b-40589b04d386
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
June 04, 2018
Package DI Number
20887787007392
Quantity per Package
50
Contains DI Package
10887787007395
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 |