Duns Number:053469565
Device Description: Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Bo Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure
Catalog Number
ISOTEC-OR
Brand Name
Oral Tamper Evident Cap
Version/Model Number
ISOTEC-OR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
e01345d7-ca9d-4a49-b9b8-61bd1c4260dc
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
B212ISOTECOR2
Quantity per Package
10
Contains DI Package
B212ISOTECOR1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |