GECKO NASAL PAD LGE - AMER 61910

GUDID 00619498619108

GECKO NASAL PAD LGE - AMER

RESMED PTY LTD

CPAP/BPAP face mask, reusable
Primary Device ID00619498619108
NIH Device Record Key85d2988e-9adf-4345-9520-d289ff7e0521
Commercial Distribution StatusIn Commercial Distribution
Brand NameGECKO NASAL PAD LGE - AMER
Version Model Number61910
Catalog Number61910
Company DUNS751149311
Company NameRESMED PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498619108 [Primary]
GS100619498619153 [Package]
Package: BOX [10 Units]
In Commercial Distribution

FDA Product Code

FMPProtector, Skin Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-14
Device Publish Date2023-06-06

Devices Manufactured by RESMED PTY LTD

00619498623006 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I STD STPK AMER
00619498623013 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I SML STPK AMER
00619498623068 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I STD STPK SLM
00619498623075 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I SML STPK SLM
00619498623082 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I STD STPK V2
00619498623099 - AirTouch N30I2024-10-11 AIRTOUCH N30I SML STPK V2
00619498623105 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I SYS - SW/STD
00619498623112 - AIRTOUCH N30I2024-10-11 AIRTOUCH N30I SYS - M/STD

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