Duns Number:219683489
Device Description: VIT.2120 HANDHELD IN2ITIVE E-DIARY WITH PENTA BAND CRADLE
Catalog Number
-
Brand Name
In2itive
Version/Model Number
2120
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
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
d784fd05-7c04-44c0-b047-d05005ed4d69
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
July 16, 2021
Package DI Number
05099169796799
Quantity per Package
1
Contains DI Package
15099169796796
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 189 |