Hippo Pediatric Nebulizer

GUDID 00616784560731

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00616784560731
NIH Device Record Key897f3ed6-4516-4d6c-8788-1ff5842443d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHippo Pediatric Nebulizer
Version Model Number5607
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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
GS100616784560717 [Unit of Use]
GS100616784560731 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-05
Device Publish Date2019-06-27

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