GUDID 06948538363188

Luna II Auto CPAP

BMC Medical Co., Ltd.

Home CPAP unit
Primary Device ID06948538363188
NIH Device Record Keydf24d60a-e155-4bfb-addc-43fb168d5aa2
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLG2A00
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-863-226-6285
Emailcpewitt@3Bproducts.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106948538363188 [Primary]

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 Number3
Public Version Date2020-02-10
Device Publish Date2018-08-31

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