Duns Number:016069284
Device Description: Glucose Control Solutions L1(Low) and L2 (High) - 2 Vials 2.5dL each
Catalog Number
942
Brand Name
Pip
Version/Model Number
942
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 13, 2026
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113208,K113208
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
21a69fca-4d73-44c1-bcf3-3abf2566a97f
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
Package DI Number
20732671309420
Quantity per Package
340
Contains DI Package
10732671209426
Package Discontinue Date
May 13, 2026
Package Status
In Commercial Distribution
Package Type
Corrugate Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |