FRUIT HEALTH

GUDID 10194422108264

100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, CLOSED BACK, SINGLE USE

Fruit of the Loom

Isolation gown, single-use

• Primary Device ID: 10194422108264
• NIH Device Record Key: b41d2a0f-ddb9-4abc-85df-47bcdbd53cd4
• Commercial Distribution Discontinuation: 2022-05-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FRUIT HEALTH
• Version Model Number: PI.421EGHT.O6J.XL.0.0
• Company DUNS: 110555005
• Company Name: Fruit of the Loom
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM
• Phone: 1-800-551-7625
• Email: FDA@FOTLINC.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00194422108267 [Primary]
GS1	10194422108264 [Package]; Contains: 00194422108267; Package: POLY BAG [10 Units]; Not in Commercial Distribution
GS1	20194422108261 [Package]; Package: CARTON [10 Units]; Not in Commercial Distribution

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-04-19

On-Brand Devices [FRUIT HEALTH]

• 10194422075542: 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
• 10194422075535: 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
• 10194422075528: 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
• 10194422108271: 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
• 10194422108264: 100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGI
• 10194422108257: 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC