JET NEBULIZER MASK , ADULT SET 7Ft OXYGEN TUBING

GUDID 04716770311111

BESMED HEALTH BUSINESS CORP.

Nebulizing system delivery set, reusable
Primary Device ID04716770311111
NIH Device Record Keyaa8b246e-a44b-479e-aa92-1bd31e37725e
Commercial Distribution StatusIn Commercial Distribution
Brand NameJET NEBULIZER MASK , ADULT SET 7Ft OXYGEN TUBING
Version Model NumberNB-31111
Company DUNS658023775
Company NameBESMED HEALTH BUSINESS CORP.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770311111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

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04716770791081 - MOUTH PIECE(OD:22mm)2020-03-23 MOUTH PIECE(OD:22mm)
04716770791098 - MOUTH PIECE (ID:18mm, OD:19.5mm)2020-03-23 MOUTH PIECE (ID:18mm, OD:19.5mm)

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