O2-MAX

GUDID 10841470109469

PULMODYNE INC

Respiratory oxygen therapy system
Primary Device ID10841470109469
NIH Device Record Key19dffe8f-1d26-44ff-a1de-deda5d06f36f
Commercial Distribution StatusIn Commercial Distribution
Brand NameO2-MAX
Version Model Number313-8018N-13
Company DUNS030619483
Company NamePULMODYNE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-246-5505
Emailinfo@pulmodyne.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470109462 [Primary]
GS110841470109469 [Package]
Contains: 00841470109462
Package: [10 Units]
In Commercial Distribution

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-11
Device Publish Date2017-08-18

On-Brand Devices [O2-MAX]

10841470110540313-7539X-1
10841470109995313-7533XN-5B
10841470111752313-8018X-5B
10841470111745313-8008X-5B
10841470111721313-8003XN
10841470111073313-8117X-11
10841470110304313-8017XN-5B
10841470110298313-8007XN-5B
10841470110007313-7533XN-5B
10841470109964313-8018N-6
10841470109957313-8008N-6
10841470109940313-7539-1
10841470109476313-8038N-13
10841470109469313-8018N-13
10841470108349313-7557XN-4
10841470108332313-7554XN-4
10841470108325313-7554XN
10841470108318313-7000-2
10841470108080313-7556-5
10841470107397313-7538XN-2
10841470107380313-8202
10841470107373313-8200
10841470107366313-8201X
10841470107359313-8007X-11
10841470107342313-8017X-11
10841470107335313-8018X-5
10841470107328313-8007X-13
10841470107311313-8017X-13
10841470107304313-7556
10841470107298313-7555
10841470107281313-8007XN-2
10841470107274313-7539XN-1
10841470107267313-7539XN
10841470107250313-8017N-6
10841470107243313-8007N-6
10841470107236313-8017XN-6
10841470107229313-8007XN-6
10841470107212313-8007XN-13
10841470107205313-8017XN-13
10841470106987313-8118
10841470106970313-8018
10841470106963313-8008
10841470106949313-8017XN-14
10841470106932313-8007XN-14
10841470105447313-8108
10841470105157313-7555XN-4
10841470105140313-7556XN-4
10841470105133313-8007N-5
10841470105126313-8017N-5
10841470105034313-8008XN-1

Trademark Results [O2-MAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
O2-MAX
O2-MAX
90533721 not registered Live/Pending
Engineered Medical Systems, Inc.
2021-02-18

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