AccessGUDID - DEVICE: CARDINAL HEALTH (10197106825150)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: SMAHBGPJSA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMAHBGPJSA
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10197106825150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: GYN PACK

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
60412	Sexual lubricant	A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAA	Aid, visual, for nausea

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 79a9afa9-8154-41e6-90dc-b9f0d36b40ab
Public Version Date: December 16, 2024
Public Version Number: 1
DI Record Publish Date: December 06, 2024