AccessGUDID - DEVICE: CARDINAL HEALTH (10885380097737)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 2150PG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2150PG
Company Name: CARDINAL HEALTH 200, LLC

Primary DI Number: 10885380097737
Issuing Agency: GS1
Commercial Distribution End Date: June 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 112164780 *Terms of Use

Device Description: GOWN ISOLATION SMS W/ HOOK LOOP CLOSURE UNIVERSAL YELLOW ELASTIC WRIST LATEX FREE NON-STERILE

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":	Yes
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?
35492	Isolation gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEA	Non-surgical isolation gown

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: 99a15a11-e050-404a-b4f6-573f118fe039
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: May 29, 2019