MiniMe 2 Pediatric Nasal Non Vented Mask, Small

GUDID 00814747022207

Pediatric nasal non vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, reusable
Primary Device ID00814747022207
NIH Device Record Key9a676cf6-2a5f-479d-820f-bd399a7a6129
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniMe 2 Pediatric Nasal Non Vented Mask, Small
Version Model Number60257
Company DUNS785635186
Company NameSLEEPNET, CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747022207 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-26
Device Publish Date2019-11-18

Devices Manufactured by SLEEPNET, CORP.

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00814747023723 - Mojo Non Vented Full Face Mask, Small with Headgear2024-04-11 Full face non vented mask for use in positive pressure ventilation.
00814747023730 - Mojo Non Vented Full Face Mask, Medium with Headgear2024-04-11 Full face non vented mask for use in positive pressure ventilation.
00814747023747 - Mojo Non Vented Full Face Mask, Large with Headgear2024-04-11 Full face non vented mask for use in positive pressure ventilation.
00814747023761 - Mojo 2 Full Face Vented Mask, Small2024-04-11 Full face vented mask for use in positive pressure ventilation.

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