BiTrac SE MaxShield

GUDID 10841470105843

CPAP/BPAP face mask, single-use

Primary Device ID	10841470105843
NIH Device Record Key	fe02ba4d-ae2e-456d-bf7e-090867f8d5e4
Commercial Distribution Status	In Commercial Distribution
Brand Name	BiTrac SE MaxShield
Version Model Number	10160046
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 Issuing Agency	Device ID
GS1	00841470105846 [Primary]
GS1	10841470105843 [Package] Contains: 00841470105846 Package: [10 Units] In Commercial Distribution

BZD	Ventilator, Non-Continuous (Respirator)

Steralize Prior To Use	false
Device Is Sterile	false