F2 Single-Patient Vented Full Face Mask Medical Device Identification

GUDID 16948538360382

CPAP/BPAP face mask, reusable

Primary Device ID	16948538360382
NIH Device Record Key	86c42626-aca8-462a-9191-710a5b5f4c6d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	BMC-FM2(Large)
Company DUNS	526010310
Company Name	BMC Medical Co., Ltd.
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Phone	+1-863-226-6285
Email	cpewitt@3Bproducts.com

Device Issuing Agency	Device ID
GS1	06948538360385 [Primary]
GS1	16948538360382 [Package] Contains: 06948538360385 Package: [15 Units] In Commercial Distribution

BZD	Ventilator, Non-Continuous (Respirator)

Steralize Prior To Use	false
Device Is Sterile	false