3B

GUDID 16948538362652

Carrying Case

BMC Medical Co., Ltd.

Home CPAP unit
Primary Device ID16948538362652
NIH Device Record Keye379ba15-d64f-4f31-adcf-f759e64a5a9b
Commercial Distribution StatusIn Commercial Distribution
Brand Name3B
Version Model NumberCC-C1-3BM
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
GS106948538362655 [Primary]
GS116948538362652 [Package]
Contains: 06948538362655
Package: [3 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 Date2022-09-06
Device Publish Date2022-08-29

On-Brand Devices [3B]

16948538362638AC/DC Power Adapter
16948538362621Power Cord American Standard
16948538362614Carrying Case
16948538362607PM2.5 Filter
16948538362591Water Chamber
16948538362669AC/DC Power Adapter
16948538362652Carrying Case
16948538362645AC/DC Power Adapter
16948538362560Water Chamber

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