AccessGUDID - DEVICE: PatientStyle (00850011216071)

GUDID

Device Identifier (DI) Information

Brand Name: PatientStyle
Version or Model: 410NB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PATIENTSTYLE MEDICAL LLC

Primary DI Number: 00850011216071
Issuing Agency: GS1
Commercial Distribution End Date: January 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 040942451 *Terms of Use

Device Description: Infant sheet printed new born. "Hatched"

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):	No
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?
11905	Patient gown, reusable	A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FME	Gown, Examination

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: 39a35f87-efc8-40d2-aede-ff080b0604e3
Public Version Date: January 30, 2025
Public Version Number: 2
DI Record Publish Date: October 15, 2019