JET NEBULIZER MASK ,CHILD SET 8CC 7Ft OXYGEN TUBIN

GUDID 04716770316215

JET NEBULIZER MASK ,CHILD SET 8CC 7Ft OXYGEN TUBING

BESMED HEALTH BUSINESS CORP.

Atomizer
Primary Device ID04716770316215
NIH Device Record Key48295f91-69b9-4412-bb6c-547940516ffc
Commercial Distribution StatusIn Commercial Distribution
Brand NameJET NEBULIZER MASK ,CHILD SET 8CC 7Ft OXYGEN TUBIN
Version Model NumberNB-31621
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770316215 [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 Date2017-12-14

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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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