Duns Number:320762776
Device Description: Warming equipment with heatable agitation plate for thawing and warming of up to 3 blood c Warming equipment with heatable agitation plate for thawing and warming of up to 3 blood components packed in plastic bags
Catalog Number
97.8710.502
Brand Name
SAHARA
Version/Model Number
SAHARA-III basic model 115V
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZL
Product Code Name
Device, Warming. Blood And Plasma
Public Device Record Key
2c87bcb2-f4c9-44f8-89f9-3c61d5c9818b
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
August 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |