Novaplus Pediatric Nasal Vented Mask, Medium

GUDID 00814747023563

Pediatric nasal vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, reusable
Primary Device ID00814747023563
NIH Device Record Keycb0de8c4-af07-4efe-8f13-a9e1605b7666
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaplus Pediatric Nasal Vented Mask, Medium
Version Model Number60224
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747023563 [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 Date2023-04-24
Device Publish Date2023-04-14

Devices Manufactured by SLEEPNET, CORP.

00814747024614 - MiniMe Pediatric Mask with Headgear, Size Small2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
00814747024621 - MiniMe Pediatric Mask with Headgear, Size Medium2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
00814747024638 - MiniMe Pediatric Mask with Headgear, Size Large2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
00814747024645 - MiniMe Pediatric Ventilation Mask with Headgear, Size Small2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
00814747024652 - MiniMe Pediatric Ventilation Mask with Headgear, Size Medium2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
00814747024669 - MiniMe Pediatric Ventilation Mask with Headgear, Size Large2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
10814747024598 - Veraseal 2 Full Face Vented Mask, Extra Large2025-02-19 Disposable full face vented mask for use in positive pressure ventilation.
10814747024413 - Novaplus Full Face Non Vented Mask, Large2025-02-13 Disposable full face non vented mask for use in positive pressure ventilation.

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