Pro-Fit

GUDID 10841470111257

PULMODYNE INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 10841470111257
• NIH Device Record Key: db792bb3-46b3-44aa-9c21-d198e1b0156c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Fit
• Version Model Number: 313-1005
• Company DUNS: 030619483
• Company Name: PULMODYNE INC
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470111250 [Primary]
GS1	10841470111257 [Package]; Contains: 00841470111250; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023683

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-30

On-Brand Devices [Pro-Fit]

• 10841470111363: 313-1020
• 10841470111356: 313-1019
• 10841470111349: 313-1018
• 10841470111332: 313-1017
• 10841470111325: 313-1016
• 10841470111318: 313-1015
• 10841470111301: 313-1014
• 10841470111295: 313-1013
• 10841470111288: 313-1008
• 10841470111271: 313-1007
• 10841470111264: 313-1006
• 10841470111257: 313-1005
• 10841470111240: 313-1004
• 10841470111233: 313-1003
• 10841470111226: 313-1002
• 10841470111219: 313-1001