AccessGUDID - DEVICE: Pjama (07350078440325)

GUDID

Device Identifier (DI) Information

Brand Name: Pjama
Version or Model: Pjama Bedwetting Shorts Blue Age 6-8 - 122/128
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2024
Company Name: Pjama AB

Primary DI Number: 07350078440325
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 350245517 *Terms of Use

Device Description: Pjama Bedwetting Pants—an innovative solution designed for children experiencing bedwetting. Pjama pants are crafted to be waterproof, breathable, and secure, ensuring a comfortable night's sleep. Experience the softness and comfort of Pjama Bedwetting Pants, providing peace of mind for both parents and children. In the event of a nighttime accident, the pants effectively contain urine, keeping the bed dry. Simply toss them in the washing machine (maximum 60 degrees C), centrifuge, hang to dry (or tumble dry), and they're ready for reuse.

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?
35120	Incontinence pants, reusable	An underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a reusable man?s brief or woman?s panty with external softness and shape resembling regular underwear, and a disposable pant liner and/or a tube that deliver the urine to a bag placed on or around one leg. The device is typically used for patients with heavy urinary incontinence in healthcare facilities or at home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYQ	Garment, Protective, For Incontinence

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: 5157cce3-076f-4232-86d5-fac40a811fbc
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023