Siesta Full Face Mask Replacement Frame

GUDID 16948538364052

Siesta Full Face Mask Replacement Frame

BMC Medical Co., Ltd.

CPAP/BPAP face mask, reusable
Primary Device ID16948538364052
NIH Device Record Key39b875d6-b6ce-47f4-b192-33436566101b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSiesta Full Face Mask Replacement Frame
Version Model NumberF5A
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948538364055 [Primary]
GS116948538364052 [Package]
Contains: 06948538364055
Package: [40 Units]
In Commercial Distribution

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-17
Device Publish Date2023-04-07

Devices Manufactured by BMC Medical Co., Ltd.

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