B&F

GUDID 00260720011230

Humidifier

ALLIED HEALTHCARE PRODUCTS, INC.

Non-heated respiratory humidifier
Primary Device ID00260720011230
NIH Device Record Keya17a96a4-c613-4f1d-b3bd-90539c97e649
Commercial Distribution StatusIn Commercial Distribution
Brand NameB&F
Version Model Number64376
Company DUNS099674145
Company NameALLIED HEALTHCARE PRODUCTS, INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100260720011230 [Primary]
GS140260720011238 [Unit of Use]

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-24

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