AccessGUDID - DEVICE: Halyard (20680651470038)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 47003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 47003
Company Name: O&M HALYARD, INC.

Primary DI Number: 20680651470038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 081057389 *Terms of Use

Device Description: HALYARD* Over-the-Head Poly-Coated Fluid Resistant Gown, Thumb Hooks, Yellow, Universal

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):	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?
35092	Patient gown, single-use	A non-sterile garment made of natural and/or synthetic materials (e.g., paper, 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 may be closed by ties at the back/side of the garment. This is a single-use 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: 335935b5-eac3-40f3-8c89-d7dafe97e742
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020