Duns Number:879057065
Device Description: ID Millennium is a Silicone Based lubricant, and is Latex Compatible.
Catalog Number
IDDMLLGA
Brand Name
ID Millennium
Version/Model Number
Millennium 128 fl oz Pump
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
K141767,K141767
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
d96c11b7-4147-4cc4-979c-f01dc7ae95dc
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
January 23, 2017
Package DI Number
10761236900898
Quantity per Package
1
Contains DI Package
00761236900891
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 56 |