3B

GUDID 16948538362591

Water Chamber

BMC Medical Co., Ltd.

Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit
Primary Device ID16948538362591
NIH Device Record Keyccd6f426-6a06-45d1-b5de-b514ab9a5386
Commercial Distribution StatusIn Commercial Distribution
Brand Name3B
Version Model NumberWT-D1
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
GS106948538362594 [Primary]
GS116948538362591 [Package]
Contains: 06948538362594
Package: [16 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 Date2022-09-05
Device Publish Date2022-08-26

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.