AccessGUDID - DEVICE: ID Millennium (00761236109928)

GUDID

Device Identifier (DI) Information

Brand Name: ID Millennium
Version or Model: Millennium 12 ml Tube
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IDDMIT10
Company Name: WESTRIDGE LABORATORIES INCORPORATED

Primary DI Number: 00761236109928
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879057065 *Terms of Use

Device Description: ID Millennium is a Silicone based lubricant, and is Latex Compatible.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUC	Lubricant, Personal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141767	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd9903cc-6419-4212-98b3-765a1e3b9ced
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 23, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00761236109942	72	00761236109928	In Commercial Distribution	Jar
00761236109935	72	00761236109928	In Commercial Distribution	Bag
60761236109920	500	00761236109928	In Commercial Distribution	Case