Rio II Full Face Mask

GUDID 16948538368272

Rio II Full Face Mask

BMC Medical Co., Ltd.

CPAP/BPAP face mask, reusable
Primary Device ID16948538368272
NIH Device Record Key9d0eb51b-4dbe-4612-9cf7-fa593313ba2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRio II Full Face Mask
Version Model NumberFPF+(Medium)
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
GS106948538368275 [Primary]
GS116948538368272 [Package]
Contains: 06948538368275
Package: [20 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 Date2024-04-08
Device Publish Date2024-03-29

On-Brand Devices [Rio II Full Face Mask]

16948538368289Rio II Full Face Mask
16948538368272Rio II Full Face Mask
16948538368265Rio II Full Face Mask
06948538368251Rio II Full Face Mask

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