GUDID 06948538360620

Siesta Full Face Mask

BMC Medical Co., Ltd.

CPAP/BPAP face mask, reusable
Primary Device ID06948538360620
NIH Device Record Key6828b090-52fa-4152-aea5-8b3038aecb73
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberF5A (Large)
Company DUNS526010310
Company NameBMC Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948538360620 [Primary]
GS116948538360627 [Package]
Package: [20 Units]
In Commercial Distribution
GS126948538360624 [Package]
Package: [18 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-10
Device Publish Date2019-06-21

Devices Manufactured by BMC Medical Co., Ltd.

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