Duns Number:480240820
Device Description: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for res OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
Catalog Number
021-211
Brand Name
OneTouch Ultramini
Version/Model Number
021-211
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061118,K061118
Product Code
NBW
Product Code Name
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Public Device Record Key
b2afd28e-ee85-4582-9f99-0b089b4cfcd1
Public Version Date
July 26, 2019
Public Version Number
4
DI Record Publish Date
September 13, 2017
Package DI Number
20353885000516
Quantity per Package
10
Contains DI Package
00353885000512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |