02-MAX

GUDID 00841470102135

PULMODYNE INC

Respiratory oxygen therapy system
Primary Device ID00841470102135
NIH Device Record Keye71ce72c-c740-4f4d-93a1-7485775c653f
Commercial Distribution StatusIn Commercial Distribution
Brand Name02-MAX
Version Model Number313-7655-5
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

Phone3172465505
Emailinfo@pulmodyne.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470102135 [Primary]
GS110841470102132 [Package]
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 Date2016-01-29

On-Brand Devices [02-MAX]

10841470102552313-8119-7
10841470102545313-8119-11
10841470102538313-8108X
10841470102521313-8117X
10841470102514313-8018X
10841470102507313-8020X-9
10841470102491313-8019X-9
00841470102487313-8107X
10841470102460313-8015X
10841470102453313-8016X
00841470102449313-8017-5
00841470102432313-8017X
10841470102422313-8017X-5
10841470102415313-8017X-7
10841470102392313-8013X
10841470102385313-8014X
10841470102378313-8012X
10841470102361313-8011X-5
10841470102354313-8011X
10841470102347313-8008X-5
00841470102333313-8131X
10841470102323313-8008-4
10841470102316313-8008X
10841470102293313-8007X-4
10841470102286313-8007X-5
108414701022793138007X-6
10841470102231313-8004X
10841470102224313-8003X
00841470102210313-8007-5
00841470102203313-8006X
10841470102187313-8002X
10841470102170313-8001X-5
00841470102135313-7655-5
00841470102128313-7655-7
00841470102111313-7655-8
00841470102104313-7656-1
00841470102098313-7656-2
00841470102081313-7656
00841470102074313-7655X
00841470102067313-7655X-5
00841470102050313-7655X-7
00841470102043313-7656-3
00841470102036313-7656-5
00841470102029313-7656-7
00841470102012313-7656-8
00841470102005313-7656X
00841470101992313-7656X-1
00841470101985313-7656X-4
00841470101978313-7656X-5
00841470101961313-7657

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