Duns Number:141588017
Device Description: SAPPHIRE 100 mL Blood Burette Set Non-Vented, 170 Micron Blood Filter, CLAVE Additive Port SAPPHIRE 100 mL Blood Burette Set Non-Vented, 170 Micron Blood Filter, CLAVE Additive Port, 112 Inch
Catalog Number
1642801
Brand Name
Sapphire
Version/Model Number
1642801
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
-
Product Code
MRZ
Product Code Name
ACCESSORIES, PUMP, INFUSION
Public Device Record Key
9822a008-84b5-4b8d-9f25-b68d38f2677c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 10, 2017
Package DI Number
20887787008382
Quantity per Package
24
Contains DI Package
10887787008385
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. | 7 |