MiniMe Pediatric Ventilation Mask with Headgear, Size Small

GUDID 00814747023051

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

SLEEPNET, CORP.

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable
Primary Device ID00814747023051
NIH Device Record Keyd9015998-5b6f-4eca-b526-0ff18cdb0295
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniMe Pediatric Ventilation Mask with Headgear, Size Small
Version Model Number60253
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747020913 [Previous]
GS100814747023051 [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 Date2022-09-14
Device Publish Date2022-09-06

On-Brand Devices [MiniMe Pediatric Ventilation Mask with Headgear, Size Small]

00814747020913Pediatric nasal non vented mask for use in positive pressure ventilation.
00814747023051Pediatric nasal non vented mask for use in positive pressure ventilation.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.