BiTrac

GUDID 10841470105508

PULMODYNE INC

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 10841470105508
• NIH Device Record Key: 4fc94ea8-a949-4fed-9d87-b9749a98ac9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiTrac
• Version Model Number: 10161578
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470105501 [Primary]
GS1	10841470105508 [Package]; Contains: 00841470105501; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972605

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: 1
• Public Version Date: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [BiTrac]

• 10841470108165: 313-9075
• 10841470108158: 313-9074
• 10841470108134: 313-9076
• 00841470108120: 313-9073
• 00841470108113: 313-9072
• 00841470108106: 313-9071
• 10841470108097: 313-9070
• 10841470109421: 313-9085
• 10841470107977: 313-9616
• 10841470107960: 313-9615
• 10841470107946: 313-9614
• 10841470107939: 313-9613
• 10841470107168: 313-9008
• 10841470107151: 313-9007
• 10841470107144: 313-9006
• 10841470107120: 313-9005
• 10841470107007: 313-9015W
• 10841470106468: 313-9016W
• 10841470106451: 313-9014W
• 10841470106444: 313-9013W
• 10841470106390: 313-9004W
• 10841470106383: 313-9003W
• 10841470106376: 313-9002W
• 10841470106369: 313-9001W
• 10841470105577: 10160052
• 10841470105560: 10160051
• 10841470105553: 10160050
• 10841470105546: 10160049
• 10841470105539: 10161576
• 10841470105522: 10161579
• 10841470105515: 10161577
• 10841470105508: 10161578