AccessGUDID - DEVICE: Quality Choice Tampons (00635515958869)

GUDID

Device Identifier (DI) Information

Brand Name: Quality Choice Tampons
Version or Model: BQCAC40
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHAIN DRUG MARKETING ASSOCIATION, INC.

Primary DI Number: 00635515958869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011920774 *Terms of Use

Device Description: Multi pack of 40 - 8 light/16 Regular/16 Super

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
35687	General-purpose implantable infusion pump, programmable	A battery-powered, sterile device designed to be implanted in a patient for the long-term or intermittent infusion of narcotics, short-acting anaesthetic agents, antineoplastic drugs, and other agents. This implantable infusion pump (IIP) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. A catheter connected to the reservoir is inserted into the epidural or subarachnoid (intrathecal) space of the spinal canal or into a blood vessel.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HEB	Tampon, Menstrual, Unscented

FDA Premarket Submission

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

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
Device Size Text, specify: Absorbency

Device Record Status

Public Device Record Key: 6bbadecf-434f-4756-8625-6ff322218e59
Public Version Date: December 09, 2019
Public Version Number: 4
DI Record Publish Date: September 20, 2016