BiTrac SE Select

GUDID 10841470104556

PULMODYNE INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 10841470104556
• NIH Device Record Key: 8e4cec5c-3705-4a20-a830-1cb22180db1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiTrac SE Select
• Version Model Number: 313-9535
• 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

Customer Support Contacts

• Phone: 317-246-5505
• Email: info@pulmodyne.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470104559 [Primary]
GS1	10841470104556 [Package]; Contains: 00841470104559; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-25

On-Brand Devices [BiTrac SE Select]

• 10841470111684: 313-9601
• 10841470109438: 313-9595
• 10841470109360: 313-9599
• 10841470106826: 313-9039W
• 10841470106772: 313-9034W
• 10841470106765: 313-9033W
• 10841470106758: 313-9032W
• 10841470106741: 313-9031W
• 10841470106727: 313-9030W
• 10841470106710: 313-9028W
• 10841470106673: 313-9064W
• 10841470106666: 313-9063W
• 10841470106567: 313-9049W
• 10841470106512: 313-9044W
• 10841470106482: 313-9041W
• 10841470106475: 313-9040W
• 10841470104907: 313-9509
• 10841470104891: 313-9546
• 10841470104884: 313-9547
• 10841470104877: 313-9548
• 10841470104846: 313-9567
• 10841470104808: 313-9597
• 10841470104709: 313-9568
• 10841470104686: 313-9566
• 10841470104648: 313-9556
• 10841470104617: 313-9553
• 10841470104594: 313-9551
• 10841470104587: 313-9538
• 10841470104570: 313-9537
• 10841470104563: 313-9536
• 10841470104556: 313-9535
• 10841470104464: 313-9508
• 10841470104457: 313-9507
• 10841470104440: 313-9506
• 10841470106659: 313-9062W
• 10841470106499: 313-9042W
• 10841470106505: 313-9043W