BiTrac HC

GUDID 10841470107564

CPAP/BPAP face mask, single-use

Primary Device ID	10841470107564
NIH Device Record Key	348d1a18-7a52-4df9-9f33-17b7b7c98557
Commercial Distribution Status	In Commercial Distribution
Brand Name	BiTrac HC
Version Model Number	313-9101
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

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

Device Size Text, specify

Device Issuing Agency	Device ID
GS1	00841470107567 [Primary]
GS1	10841470107564 [Package] Contains: 00841470107567 Package: [10 Units] In Commercial Distribution

BZD	Ventilator, Non-Continuous (Respirator)

Steralize Prior To Use	false
Device Is Sterile	false