Duns Number:051957769
Device Description: ReliOn Ultima Blood Glucose Test Strips
Catalog Number
70122
Brand Name
ReliOn Ultima
Version/Model Number
70122
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083223,K083223,K083223
Product Code
JJX
Product Code Name
Single (specified) analyte controls (assayed and unassayed)
Public Device Record Key
665c76b5-5e16-4c81-abb2-cce9350e6c6c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 05, 2018
Package DI Number
30681131060319
Quantity per Package
6
Contains DI Package
00681131060318
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |