FRUIT HEALTH

Basic Information

• Brand Name: FRUIT HEALTH
• Primary DI: 00194422075545
• Version / Model: PI.408EGHT.O6J.L.0.0
• Company Name: Fruit of the Loom
• Labeler DUNS: 110555005
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-11
• Public Version: 2
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: fd5274bd-37f8-4da5-8d10-4a6305a24b47
• Distribution End Date: 2022-05-01

Device Description

100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, OPEN BACK, NOT PROTECTED, SINGLE USE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEA	Non-Surgical Isolation Gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10194422075542	GS1	POLY BAG	10	Not in Commercial Distribution	2022-05-01
Primary	00194422075545	GS1
Package	20194422075549	GS1	CARTON	10	Not in Commercial Distribution	2022-05-01

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			LARGE