Com-Fit

GUDID D6870020361SA1

0

Sultan Healthcare Inc

Surgical/medical face mask, single-use

• Primary Device ID: D6870020361SA1
• NIH Device Record Key: 8c31bd75-375a-4f36-b520-4c05d675013c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Com-Fit
• Version Model Number: 0020361SA
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)989-8825
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6870020361SA0 [Unit of Use]
HIBCC	D6870020361SA1 [Primary]

FDA Product Code

• FXX: Mask, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-07-18

Devices Manufactured by Sultan Healthcare Inc

• D687215200 - ReSURGE™: 2022-12-13 ReSURGE™ Instrument Cleaning Solution 24x1/2 oz (14.8 mL) Packets
• D687215211 - ReSURGE™: 2022-12-13 ReSURGE™ Instrument Cleaning Solution 1L (33.8 oz)
• D687AD320120 - Topex®: 2022-12-13 Topex® Dual Arch Tray Medium Bag of 50
• D687AD33004FG0 - 3-Way: 2022-12-13 3-Way Disposable Impression Tray- Posterior Sideless (50 per box)
• D687AD320100 - Topex®: 2022-12-12 Topex® Dual Arch Tray Pedo Bag of 50
• D687AD320110 - Topex®: 2022-12-12 Topex® Dual Arch Tray Small Bag of 50
• D687AD320130 - Topex®: 2022-12-12 Topex® Dual Arch Tray Large Bag of 50
• D687AD321010 - Topex®: 2022-12-12 Topex® Single Arch Tray Small Bag of 100