AccessGUDID - DEVICE: Kotex (07702425810853)

GUDID

Device Identifier (DI) Information

Brand Name: Kotex
Version or Model: Liner
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KIMBERLY CLARK COLOMBIA HOLDING LTDA

Primary DI Number: 07702425810853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 120
Labeler D-U-N-S® Number*: 881043603 *Terms of Use

Device Description: PRO DIA KOT PURE REG 12X120

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:	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?
40545	Menstrual pad, unscented	A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRC	Pads, menstrual, scented-deodorized

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: 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: fc8161f0-280a-4bb0-8b1f-b23214e79631
Public Version Date: December 23, 2021
Public Version Number: 1
DI Record Publish Date: December 15, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17702425810850	12	07702425810853		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 07441008100232 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +576014049046
Email: sac.kimberly@kcc.com

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