Hall Breathe

GUDID 06973280040032

Huizhou Kaiyi Technology Co., Ltd.

Incentive spirometer
Primary Device ID06973280040032
NIH Device Record Key30262a31-9a98-49b6-b662-c554f9ab5e4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHall Breathe
Version Model NumberVIS-05
Company DUNS403829094
Company NameHuizhou Kaiyi Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973280040032 [Primary]

FDA Product Code

BWFSpirometer, Therapeutic (Incentive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

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